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 Editor’s Letter 3 – Issue N°3 – June 2009

New pandemics mustn’t mask existing problems.

Amid huge publicity infectious diseases (TB, HIV/AIDS, which continues to wreak havoc in the note, there seems to be (at last) real
and in suitably som- malaria) occurs in the developing less-developed world. There are more hope for the development and testing
bre tones, Dr Marga- countries, i.e. conveniently out of sight deaths of African children as a result of malaria vaccines.
ret Chan,the Director of the Western world and its press. of malaria in one hour (!) than the The message is that the struggle
General of the World The reality is that the WHO is hugely total deaths so far caused by A(H1N1) for improved global health should
Health Organisation concerned about all such diseases. By a infection in the whole course of the be fought on all fronts, i.e. against
(WHO) announced coincidence of timing, only two weeks ‘flu pandemic. In addition, there are existing scourges as well as against
on June 11th that the world is now before the ‘flu pandemic announce- ominous reports of the emergence of new pandemics.
officially at the start of the first pan- ment the WHO organised their (much malaria cases resistant to artemisin,
demic of the new century, namely that less reported) World Malaria Day to the drug that is the mainstay of cur-
caused by the novel H1N1 strain of highlight the severity of the disease rent malaria treatments. On a positive
influenza. This conclusion was based
on the application of strict WHO
criteria regarding transmission of
the virus. With a total of 55000 cases
of swine ‘flu having been reported
worldwide to date, it was clear that the
spread of the virus in several coun-
tries was no longer traceable to clearly
defined chains of human-to-human
transmission. The definition of pan-
demic was therefore fulfilled and con-
sequently the WHO raised its ‘flu alert
level from 5 to 6, which is the highest
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in reality to be very mild. With, to date,
“only” 238 patients worldwide having
died from the disease, and even then
many of these having co-morbidities,
we’re far from the nightmare scenarios
like that of the Spanish ‘flu in 1919
when approximately 50 million people
died. The suspicion grew that the hul-
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 – Issue N°3 – June 2009 6 Paediatrics and neonatology

Neonatal nutrition: a brief review

The ultimate goal for growth of the infant in the neonatal intensive care unit (NICU) is be started rather than decreasing the dextrose
replication of in utero growth. Due to the immaturity of the premature’s gut, it is often concentration to less than 5% [3].
difficult to achieve full enteral feeds in a timely fashion. In addition, mother’s breast
Lipid
milk is not sufficient to match in utero growth of the extremely premature infant. It is Intravenous (IV) lipids provide a source of essen-
however difficult to meet in utero growth accretion with strictly parenteral nutrition tial fatty acids to parenterally fed infants, in addi-
and complications of parenteral nutrition may cause severe problems for the prema- tion to providing a calorie-dense source of nutri-
tion. The exact composition of the lipid solution
ture. This article briefly reviews some of the current concepts surrounding the use of
varies by manufacturer. The most commonly used
total parenteral nutrition (TPN), some of the challenges involved in matching in utero lipid formulation in the United States, Intralipid,
growth parameters and complications of long-term parenteral nutrition. uses soybean oil as a base. Different formulations
are available in Europe, including some that use
by Dr David L. Schutzman, Dr Rachel Porat, Dr Agnes Salvador & Dr Michael Janeczko medium chain triglycerides (MCT).

Starting IV lipid in very low birth weight VLBW

Amino acids (AA)
Protein deficit early in the neonatal period is
an important contributor to poor growth, par-
ticularly in extremely low birth weight infants
(ELBW). Replication of intrauterine growth and
nutrient accretion is difficult for ELBW infants
due to their high rate of protein turnover and
catabolism. Studies have shown that negative
nitrogen balance in sick premature infants who
received glucose alone can be reversed with an
amino acid (AA) intake of 1.1-2.5 g/kg/day given
early postnatally [1], [Figure 1].
Poindexter, in a study for the NICHD (National
Institute of Child Health and Development)
Research Network, demonstrated that 3 g/kg of
amino acids in the first five days of life in pre-
mature infants was associated with significantly
better outcomes at 36 weeks postmenstrual age
(gestational age plus chronological age) and less
suboptimal head growth at 18 months chrono-
logic age [2]. The efficiency of protein retention
during parenteral nutrition is approximately
70%. Based on this assumption and the proven
benefits of early AA intake in limiting protein
catabolism, it is reasonable to recommend 2.5 –
3.0 g/kg/day of AA intake directly after birth in
premature infants. Parenteral protein of 3.5-4
g/kg/day may be required in ELBW infants to
maintain endogenous stores, taking into account
accretion goals and the rate of protein loss in the
neonatal period.
glucose between 40-50 mg% and 150 mg% [3].
This necessitates the initiation of an intra-
venous glucose infusion at a rate of roughly
6 mg/kg/min in the premature immediately
following birth.
Hyperglycaemia is quite common in the
extremely premature infant and has been asso-
ciated with a number of significant morbidities
including sepsis, intraventricular haemorrhage,
retinopathy of prematurity and ultimately
death. It is most commonly caused by low insu-
lin levels due to defective proinsulin process-
ing, and relative insulin resistance due to the
stress response [4].
A glucose infusion of 6 mg/kg/min should be
started on all premature infants upon admis-
sion to the nursery. This should be gradually
increased to 10 mg/kg/min over the first week
of life. The infant’s blood glucose level should
be maintained between 50-120 mg%. Should
the infant become hyperglycaemic early on, an
insulin infusion (0.01-0.1 units/kg/hr) should
infants at an early age has the advantage of pro-
viding a source of essential fatty acids, as well as
supplying non-carbohydrate calories. Essential
fatty acid deficiency can develop in as few as three
days in extremely premature infants. Lipid infu-
sion may be safely started on day 1 of life at 0.5-
1.0 g/kg/day and may be increased by up to 1 g/
kg/day to a maximum of 3-4 g/kg/day [5]. Trig-
lyceride levels should be followed and lipid infu-
sion temporarily discontinued if the triglyceride
level exceeds 150-200 mg/dL [5].
There have been alternative lipid infusions pro-
posed that differ in composition from current
solutions. A recent review paper summarised
several in vitro and in vivo studies comparing
olive oil to soybean oil-based intralipid prepara-
tions [6]. Olive oil solutions contain decreased
concentrations of n-6 poly unsaturated fatty
acid (PUFA) which has been noted to adversely
affect leukocyte recruitment, and also contain
α-tocopherol, a naturally occurring antioxidant.
Olive oil-based infusions are well tolerated, and
may offer advantages for immune function and

Carbohydrate
In utero the foetus’ glucose utilisation matches
the umbilical glucose uptake; hence, there is
no need for either glycogenolysis or gluconeo-
genesis. This changes upon birth. In the term
infant, glucose utilisation is 3-5 mg/kg/min,
however utilisation in the premature may be
as high as 8 mg/kg/min. The exact definition
of both hypoglycaemia and hyperglycaemia
has remained problematic. However, it seems Figure 1. Protein balance in response to intravenous amino acid administration in extremely low
prudent to maintain a premature infant’s blood birth weight (ELBW) infant in early post-natal life [Ref 1].

decreased oxidative stress in the very-low birth
weight infant.
Complications of TPN
Although TPN is necessary to provide nutrition
to the VLBW neonate, there are several compli-
cations associated with its administration. Pro-
longed TPN therapy frequently necessitates plac-
ing a central IV catheter whose use carries with
it several risks, including nosocomial infections,
vascular thrombosis and cardiac tamponade.
TPN associated cholestasis (TPNAC) has long
been recognised as a metabolic complication of
chronic TPN administration. It is characterised
by intracanalicular and intracellular cholesta-
sis. It has been reported that 8-50% of ELBW
infants show signs of biochemical cholestasis
after two weeks of TPN therapy. The incidence
approaches 90% in infants who receive TPN for
> 90 days [7]. The pathophysiology of PNAC
is still incompletely understood, but felt to be
multifactorial in aetiology.
Recent studies have focused on soybean oil-
based lipid solution as possibly being causative of
TPNAC. Phytosterols in soybean oil can damage
the biliary tract and disrupt bile flow. A clinical
study was performed on infants with PNAC while
receiving soybean oil-based lipid emulsions. They
were given fish oil-based lipid emulsions, and
compared to an historical cohort that received
soybean oil-based emulsions only. The fish oil
group had a significantly shorter time to reversal
of cholestasis compared to the soybean oil group
(9 vs. 44 weeks) [8]. Treatment for TPNAC is
focused on making the transition to enteral feeds
as soon as possible. Other interventions include
ursodeoxycholic acid, a bile acid used in adult
cholestatic liver disease. Its efficacy in treating
and preventing TPNAC is controversial, as stud-
ies have not consistently shown benefit.
Enteral feeding
Optimal early nutrition is critical for growth,
long-term outcome and decreased morbidities
in the low birth weight preterm (LBW). The goal
is to achieve a growth rate similar to in utero
foetal growth: 15-20 g/kg/d, which requires 120
cal/kg/d enterally [9]. Attempts should be made
to begin enteral feedings as soon as possible.
Minimal enteral nutrition, or trophic feedings,
is highly recommended to “prime” the GI tract
with very low volume feedings. It stimulates gut
hormones and promotes structural and func-
tional intestinal maturation, decreases indirect
hyperbilirubinaemia and decreases cholestatic
jaundice [9]. It can result in improved feeding
tolerance, a shorter hyperalimentation course,
better weight gain and improved bone minerali-
sation. Even sick VLBW infants can be started on
small trophic feedings (2-20 ml/kg/d) of human
milk (HM) or premature formula (PF) as early
as 1-8 days of life, if haemodynamically stable.
7 – Issue N°3 – June 2009
Advancement to full enteral feedings depends
on the infant’s clinical condition and tolerance.
Human milk is the preferred source of enteral
nutrition for all infants due to its better digestion
and absorption, improvement in host defense
and improved neurodevelopmental outcomes
[9]. It is highly recommended to use human
milk fortifier (HMF) for ELBW infants to assure
the adequacy of HM and to avoid hyponatrae-
mia, hypoproteinaemia, osteopenia and zinc
deficiency. HMF provides additional protein,
minerals (Ca, P) and vitamins and is recom-
mended for preterm infants born at <34 wks
gestation with birth weight <1500 g, or to larger
infants with the need to limit volume intake
or with suboptimal growth. When HM is not
available, premature formulae (PFs) will be the
primary source of nutrition. Pre-term infants
born at >34 wks gestation and >2.0 kg may
feed standard term formula if HM is not avail-
able. Nutrient-enriched “Discharge Formula”
(22 cal/oz, 0.78cal/g) is also an option. This is
more energy- and nutrient-dense than standard
formula and less dense than preterm formula.
The VLBW infant’s nutritional status needs to
be assessed daily for weight, fluid and nutrient
intake, weekly for length and head circumfer-
ence and biweekly for biochemical markers such
as Hgb, Hct, Ca and P [10]. Weight gain of <10
g/day after day 21 of life with caloric intake of >
24-26 kcal/oz ( > 0.85 - 0.92 kcal/g) may be an
indication for caloric supplements such as MCT
oil and Polycose [10].
Conclusion
Ultimately the goal of neonatal nutrition is to try
to replicate in utero growth patterns. While this
is often not possible, particularly in the smallest
infants, this article suggests several management
strategies to try to reach this goal. Amino acids of
as much as 3 g/kg/day should be started parenter-
ally as part of the infant’s initial IV solution. Glu-
cose at a rate of 6 mg/kg/min should be started
immediately after birth. Severe hyperglycaemia
should be managed with an insulin infusion if
the infant remains hyperglycaemic on a 5% dex-
trose infusion. An IV lipid solution of 1 g/kg/day
should be started as early as day one or two of life.
Enteral feeds, preferably of breast milk, should be
started within the first few days of life even in crit-
ically ill infants as long as they are haemodynami-
cally stable. The major complication of parenteral
nutrition, namely TPN associated cholestasis,
is ultimately treated by advancing enteral feeds.
Newer lipid preparations, however, show some
promise in reversing the hepatic damage of
prolonged TPN.
References
1. Denne SC, Poindexter BB. Evidence supporting early
nutritional support with parenteral amino acid infu-
sion. Semin Perinatol 2007; 31:56-60
2. Poindexter BB, Langer JC. Early provision of
parenteral amino acids in extremely low birth weight
infants: relation to growth and neurodevelopmental
outcome. J Pediatr 2006; 148: 300-5
3. E hrenkranz RA. Early, aggressive nutritional man-
agement for very low birth weight infants: what is the
evidence? Semin Perinatol 2007; 31: 48-55.
4. Mitanchez-Mokhtari D, Lahlou N, Magny JF et al.
Both relative insulin resistance and defective islet
beta-cell processing of proinsulin are responsible
for transient hyperglycemia in extremely preterm
infants. Pediatrics 2004; 113: 537-41
5. Valentine CJ, Puthoff TD. Enhancing parenteral nutri-
tion therapy for the neonate. Nutr Clin Pract 2007;
22: 183-93.
6. Sala-Vila A, Barbosa VM, Calder PC. Olive oil in
parenteral nutrition. Curr Opin Clin Nutr Metab
Care 2007; 10: 165-174
7. Forchielli ML, Walker WA. Nutritional factors con-
tributing to the development of cholestasis dur-
ing total parenteral nutrition. Adv Pediatr 2003;
50: 245-268.
8. Gura KM, Lee S, Valim C et al. Safety and efficacy
of a fish-oil-based fat emulsion in the treatment
of parenteral nutrition-associated liver disease.
Pediatrics 2008; 121: e678-686.
9. Yu VYH, Simmer K. Enteral nutrition: practical
aspects, strategy and management. In Tsang RC,
Uauy R, Koletzko B, Zlotkin SH eds. Nutrition of
the preterm Infant-Scientific Basis and Practical
Guidelines (ed 2). Cincinnati, OH, Digital Education
Publishing, Inc. 2005: 311-332
10. Campbell J, Conkin C, Montgomery C, Phillips S,
Wade K eds. Texas Children’s Hospital Pediatric
Nutrition Reference Guide (ed 7). Houston TX,
Texas Children’s Hospital. 2005: 22-40
The authors
David L. Schutzman, MD, Rachel Porat, MD,
Agnes Salvador, MD, Michael Janeczko, MD
Each of the authors researched and wrote at least
one section of this review. Dr. Schutzman was
responsible for final editing. Dr. Schutzman is the
guarantor of this review.
Department of Pediatrics, Division of Neonatology
Albert Einstein Medical Center
5501 Old York Road
Philadelphia, PA 19141, USA
Corresponding author:
David L. Schutzman, MD
5501 Old York Road
Lifter Bldg., Suite 2601
Philadelphia, PA 19141, USA
Tel +1 215 456 6698
Fax +1 215 456 6769
email- schutzmand@einstein.edu
Comments on this article?
Feel free to post them at
www.ihe-online.com/comment/TPN
 – Issue N°3 – June 2009
Neonatal coagulation disorders
Neonatal coagulation disorders frequently present diagnostic and therapeutic chal-
lenges, and can be life-threatening unless treatment is appropriately administered.
Therefore, a step-wise approach to the neonate with a suspected coagulation
disorder is vital to a successful outcome.
by Dr M A Saxonhouse and Dr M C Sola-Visner
The neonatal haemostatic system
The neonatal coagulation system is markedly
different from that of adults, and for that rea-
son age-appropriate reference ranges have to be
applied when interpreting neonatal coagulation
test results [1]. In addition, in the neonatal period
there is a striking lack of correlation between the
antigen levels of some coagulation protein and the
results of activity assays; it is in general recom-
mended to use functional assays for testing [2].
Interestingly, while the levels of many individual
coagulation factors are reduced in neonates com-
pared to adults, whole blood coagulation assays
have demonstrated that the overall haemostatic
ability of healthy full term infants is equal to —
or somewhat more robust than — that of adults
[3]. This suggests the existence of a delicately bal-
anced neonatal haemostatic system, which can be
disrupted under certain conditions and shifted
toward either haemorrhage or thrombosis.
Bleeding disorders of the neonate
Unexplained bleeding in a healthy term or late pre-
term infant with a normal platelet count is sugges-
tive of a bleeding disorder. Common presentations
of a neonatal bleeding disorder are listed in Table
I, and an approach to the evaluation of neonates
with a suspected congenital or acquired bleeding
disorder is presented in Figure 1. Age-adjusted lev-
els of procoagulant, anticoagulant and fibrinolytic
proteins have been published [1, 4].
Haemophilia
Haemophilias A and B are characterised by defi-
ciencies of Factor VIII and IX, respectively. Haemo-
philia should be suspected in any bleeding neonate
with an isolated prolongation of the activated par-
tial thromboplastin time (APTT). Neonatal Fac-
tor VIII levels are within the normal adult range
in both term and pre-term infants, thus allowing
for the diagnosis of Haemophilia A to be made in
the neonatal period. Factor IX activity, in contrast,
can be as low as 15% in healthy term infants and
does not reach normal adult levels until late in the
first year of life; therefore only moderate to severe
haemophilia B can be confirmed in neonates.
Treatment for haemophilia A or B is recombinant
Factor VIII or Factor IX concentrate, respectively
[5]. Fresh frozen plasma (FFP) should be used
only in the instance of acute haemorrhage when
confirmatory testing is not yet available [6].
8 Paediatrics and Neonatology
• Umbilical stump oozing
• Post-venipuncture/heel stick bleeding
•S
 ignificant caput succedaneum and/
or cephalohematomas without significant birth trauma
• Prolonged post-circumcision bleeding
• Intracranial hemorrhage in a term or late preterm infant
Table 1. Signs and symptoms of neonatal
bleeding disorders.
Von Willebrand Disease (vWD)
Von Willebrand disease rarely presents during the
neonatal period, but the diagnosis is suggested by
an isolated prolonged APTT, low levels of Fac-
tor VIII, absent or decreased vWF antigen and
activity levels, and prolonged adrenaline and ADP
closure times, as measured by the PFA-100.
Rare coagulation disorders
Rare coagulation deficiencies usually present with
an abnormality in coagulation screening tests.
Following the screening test results, specific factor
levels should be evaluated [Figure 1] in order to
make the correct diagnosis and institute adequate
treatment [7].
Vitamin K deficiency
Vitamin K deficiency bleeding (VKDB) can present
in three forms namely: early (within 24 h of life);
classical (1 -7 days of life, DOL) or late ( 2 -12 wks
of life. Although the causes of VKDB differ accord-
ing to the form, the symptoms are generally intrac-
ranial haemorrhage (ICH), although in the classical
form there can also be skin bruising or bleeding fol-
lowing circumcision. When presented with VKDB,
vitamin K should be immediately administered,
preferably subcutaneously, which will start short-
ening the PT within four hours. Oral vitamin K can
be used if absorption is unimpaired, but correction
will take 6-8 hours. In the setting of acute haemor-
rhage, FFP should be administered [8], especially
if the diagnosis is not confirmed. In the United
States, all infants receive 1.0 mg of intramuscular
(IM) vitamin K on the first day of life (0.3mg for
infants <1000g and 0.5mg for infants>1000g but
<32 weeks gestation) [9].
Disseminated Intravascular
Coagulation (DIC)
A diagnosis of DIC should be entertained in an
ill neonate with thrombocytopenia, prolonged
PT and APTT, reduced fibrinogen and increased
D-dimers. Treating the underlying cause (sepsis,
hypoxia, and/or acidosis) is mandatory. The pres-
ence of DIC in a neonate without any evidence
of sepsis or history of asphyxia should prompt
evaluation for a capillary haemangioma or for a
large arteriovenous malformation. Maintaining
adequate haemostasis is important to limit haem-
orrhage [7]; this can be achieved with platelet
transfusions (goal platelet counts > 50,000/µL or
100,000/µL if actively bleeding or following recent
surgery), FFP and cryoprecipitate (goal fibrino-
gen levels ≥ 100 mg/dL, and PT ≤ 3 seconds above
upper limit of normal) [10].
Pathologic neonatal thrombosis
Neonatal thromboembolic (TE) events occur in
approximately 5.1 per 100,000 live births, [11];
venous TE events are frequently (~90%) associ-
ated with central venous catheters [12]. Different
types of neonatal thromboses, common locations
and presenting symptoms are listed in Table 2.
Ischaemic Perinatal Stroke (IPS)
Ischaemic perinatal stroke occurs between 20
weeks of foetal life until the 28th postnatal day
[13]. The region of the brain most commonly
affected is the left hemisphere, within the distri-
bution of the middle cerebral artery [14]. Current
guidelines from the American College of Chest
Physicians (ACCP) recommend supportive care
for most neonates with IPS, and reserve antico-
agulation with unfractionated heparin (UFH) or
low molecular weight heparin (LMWH) only for
neonates with either proven cardioembolic stroke
or recurrent ischaemic perinatal stroke [15].
Iatrogenic/spontaneous
arterial thromboses
Iatrogenic arterial thromboses are mainly related
to umbilical arterial catheters (UACs), peripheral
arterial catheters or lines (PALs) and femoral arte-
rial catheters. Spontaneous arterial thromboses
are extremely rare, and usually involve the aorta,
thus frequently making them life-threatening.
Figure 1. Evaluation of neonatal bleeding disorders.
If the patient presents with isolated thrombocytopenia,
refer to appropriate evaluation for neonatal thrombo-
cytopenia [30]. Figure adapted with permission [29].
PT: prothrombin time APTT: activated partial
thromboplastin time.

Type of
Blood Type/Location
Vessel
Ischemic Perinatal Stroke
Arterial
Iatrogenic/Spontaneous* (aorta, or
large arterial vessel)
Catheter related
Intracardiac (right atrium)
Venous
Renal vein thrombosis
Cerebral sinovenous thrombosis
Portal venous thrombosis
*Mainly related to umbilical arterial and peripheral arterial catheters
Table 2. Pathologic neonatal thromboses.
Complications of UACs include mesenteric ischae-
mia, hypertension, renal dysfunction/failure, limb
loss and congestive heart failure [2, 16]. High UAC
positioning has been associated with fewer clinical
complications [15]. Suspicion or confirmation of an
arterial thrombosis should prompt removal of any
associated arterial catheter. Treatment is focused on
restoration of blood flow and includes supportive
care, anticoagulation with UFH or LMWH, fibri-
nolytic therapy and/or surgery. Recommendations
for neonatal arterial thromboses are to treat with
UFH or LMWH for at least 10 days. Thromboly-
sis with recombinant tissue plasminogen activa-
tor (rTPA) should be limited to patients with life-,
limb- or organ-threatening arterial thromboses,
and careful attention should be given to contrain-
dications [15]. These different treatment modalities
will be discussed later in detail.
Catheter related venous thrombosis (non-
cardiac): umbilical venous catheters and
peripherally inserted venous catheters
Due to the high complication rates from umbili-
cal venous catheters (UVCs), the US Centers for
Disease Control and Prevention (CDC) have rec-
ommended that the use of UVCs be limited to 14
days [17]. Long term complications of venous TE
include chronic venous obstruction with cuta-
neous collateral circulation, chylothorax, portal
hypertension and post-thrombotic syndrome [18].
Suspicion or confirmation of a venous thrombus
warrants either prompt catheter removal, or 3-5
days of anticoagulant therapy followed by cath-
eter removal (to reduce the risk for emboli at the
time the catheter is pulled out) [15]. While the lat-
ter is an approach favoured by many physicians,
Maternal Risk Factors Delivery Risk Factors
Infertility and its treatment Emergent cesarean section
Oligohydramnios Severe bradycardia
Thrombotic states during pregnancy Instrumentation
Preeclampsia
Diabetes
Chorioamnionitis
Prolonged rupture of membranes
Autoimmune disorders
Table 3. Risk factors for pathologic neonatal thromboses. With permission [26].
9 – Issue N°3 – June 2009
provide either supportive care with monitoring for
Presenting Symptoms Imaging Modality extension or anticoagulation with UFH or LMWH
for up to three months. In cases of unilateral RVT
Seizures, lethargy, apnea, poor feeding MRI with extension into the IVC, anticoagulation with
UFH or LMWH should be instituted for three
Line dysfunction, extremity blanching and/or
Contrast angiography months. Thrombolytic therapy plus anticoagula-
cyanosis, pulseless extremity, thrombocytopenia,
Ultrasound
acute renal failure
tion with UFH, followed by anticoagulation with
Persistent infection, persistent thrombocytopenia, Ultrasound/echocardiography
UFH or LMWH, should be reserved for patients
line dysfunction. CT or MRI with bilateral RVT and renal failure [15].
Infection, right heart failure Echocardiography
Cerebral sinovenous thrombosis
Macroscopic hematuria, palpable abdominal
Ultrasound
The superior and lateral sinuses are the most fre-
mass, thrombocytopenia, hypertension
quent sites of cerebral venous thrombosis and up
Seizures, fever, lethargy MRI to 30% of cases present with venous infarction and
subsequent haemorrhage. Current recommenda-
Thrombocytopenia, liver failure Ultrasound
tions are to start UFH or LMWH only in neonates
without significant intracerebral haemorrhage,
followed by LMWH for a minimum of six weeks
there are no studies to support this practice, so it and a maximum of three months [15]. For patients
remains at the physician’s discretion. who are not anticoagulated, radiological monitor-
ing of the thrombus at 5-7 days is recommended,
Intracardiac thromboses and and anticoagulation should be initiated if there is
thromboses in infants with complex evidence of thrombus propagation [15].
congenital heart disease
Complications of central venous catheters in Risk factors for neonatal
the right atrium include damage of the endocar- thromboembolism (TE)
dium, pericardial tamponade and/or intracardiac Acquired and genetic risk factors implicated in
thrombi [19]. Thrombus formation in the right the pathogenesis of neonatal TE are listed in Table
atrium is particularly worrying due to the high 3. Registry data and case studies have demon-
risk of dissemination of emboli into the lungs or strated that the majority of symptomatic neonatal
obstruction of the right pulmonary artery. Sur- thromboses, particularly spontaneous events (i.e.
gical removal of the thrombus is not feasible in not catheter-related), are associated with either
most cases, and there have only been case reports
Medcorp International
using rTPA for thrombolysis of catheter-related
atrial thromboses in neonates [20]. Superior
vena cava thrombosis is a common complica-
tion in infants undergoing repair of complex
congenital heart disease [21]. A recent evaluation
of 22 neonates who underwent palliative cardiac
repair between one and 11 days of life found that
23% had evidence of thrombi over a range of
four hours to nine months postoperatively [21].
Interestingly, the authors of that study found an
association between thrombotic events and high
pre-operative values of C-reactive protein (CRP).
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 – Issue N°3 – June 2009 10 Paediatrics and Neonatology

multiple prothrombotic defects or the combina- Clinical

Medication Traditional Dosing Current Recommended Dosing
Potential
Indication Complications
tion of prothrombotic defects and other acquired
< 28-weeks gestation: 25 units/kg IV over 10
risk factors [12, 22, 24]. Therefore, it is currently minutes, then 15 units/kg/hour
Asymptomatic or
recommended that neonates with thrombosis symptomatic thrombus
75 units/kg IV over 10
28-37-weeks gestation: 50 units/kg over 10 minutes,
Bleeding
UFH minutes, then 28 units/ Heparin induced
(regardless of risk factors) undergo testing for a full but non-limb or organ
kg/hour
then 15 units/kg/hour
thrombocytopenia
threatening
panel of genetic prothrombotic traits [25]. >37-weeks gestation: 100 units/kg over 10 minutes,
then 28 units/kg/hour

Management of neonatal thrombosis Asymptomatic or

symptomatic thrombus LMWH
1.5 mg/kg SQ q 12 Term Neonates 1.7 mg/kg SQ q 12 hours
Bleeding
hours
If anticoagulation or thrombolysis are deemed nec- but non-limb threatening Preterm Neonates 2.0 mg/kg SQ q 12 hours

essary, the current dosing guidelines listed in Table Limb/life threatening 0.06 mg/kg/hour +
rTPA N/A Bleeding
4 should be used. Before initiating antithrombotic thrombus UFH at 10 units/kg/hour

therapy, however, the clinician must decide that the
benefits of therapy outweigh its risks, especially in
the premature infant. In regard to anticoagulation
treatment, the choice is either UFH or LMWH.
UFH has a short half-life, thus allowing for rapid
dose adjustments and discontinuation of therapy.
This makes it an attractive option in the pre- or
post-operative period. However, the lower levels of
antithrombin and increased rate of heparin clear-
ance in neonates, and the requirement for continu-
ous IV access and frequent monitoring can com-
plicate UFH therapy in neonates. LMWH therapy
in neonates is associated with decreased bleeding
risk, does not require venous access and monitor-
ing is easier [2]. Furthermore, the placement of a
subcutaneous catheter can dramatically reduce
the number of subcutaneous injections. However,
LMWH has a longer half-life and needs to be dis-
continued 12-24 hours prior to any invasive pro-
cedure. Based on these characteristics [Table 4],
UFH is recommended for short-term anticoagula-
tion (less than one week), especially if surgery is
indicated within the next 72 hours. If long term
anticoagulation is desired, then LMWH is a more
practical choice in the NICU.
Due to its high bleeding risk, the use rTPA in
neonates should only be considered for limb- or
organ-threatening thrombosis and for acute atrial
thromboses [2, 15]. Absolute and relative con-
traindications to thrombolytic therapy are listed
in Table 5.
Conclusion
The lack of randomised clinical trials addressing
Table 4. Recommended therapy and dosing of neonatal antithrombotic agents.
Adapted with permission [28].
treatment. Randomised clinical trials investigating
treatment options for neonatal haemorrhage and
thrombosis are critically needed.
References
Note: a complete bibliography is available from the
authors, as are details of all in vitro diagnostic procedures
recommended for the diagnosis and monitoring of the
various disorders.
1.Andrew M et al. Blood 1988; 72: 1651.
2. Thornburg C &, Pipe S. Semin Fetal Neonatal Med
2006;11:198.
3. Edwards RM et al. Am J Clin Pathol 2008; 130: 99.
4. Andrew M et al. Am J Pediatr Hematol Oncol 1990; 12: 95.
5. Guidelines on the selection and use of therapeutic products
to treat haemophilia and other hereditary bleeding disor-
ders. Haemophilia 2003; 9: 13.
6. Kulkarni R & Lusher J. Br J Haematol 2001; 112: 264.
7. Goldenberg NA & Manco-Johnson MJ. Best Pract Res Clin
Haematol 2006; 19: 143.
8. Flood VH et al. Pediatr Blood Cancer 2008; 50: 1075.
9. Young TE & Mangum B. NEOFAX 2008. 21 ed. Vol. 1
Montvale: Thomson Reuters; 2008.
10. G uidelines for the use of platelet transfusions.
Br J Haematol 2003;122: 10.
11. Nowak-Gottl U et al. Arch Dis Child Fetal Neonatal Ed
1997; 76: F163.
12. van Ommen CH et al. J Pediatr 2001; 139: 676.
13. Raju TN et al. Pediatrics 2007; 120: 609.
14. Hunt RW & Inder TE. Thromb Res 2006; 118: 39.
15. Monagle P et al. Chest 2008; 133: 887s.
16 Nouri S et al. Arch Pediatr 2007; 14: 1097.
24. Kenet G & Nowak-Gottl U. Obstet Gynecol Clin North
Am 2006; 33 : 457.
25. Manco-Johnson MJ et al. Thromb Haemost 2002; 88:
155.
26. Saxonhouse MA & Manco-Johnson MJ. Semin Perinatol
2009; 33: 52.
27. Manco-Johnson MJ. Blood 2006; 107: 21.
28. Manco-Johnson MJ in Hematology, Immunology, and
Infectious Disease: Neonatology Questions and Contro-
versies. Ohls R, MC Y, eds. Vol. 1. Philadelphia: Saunders
Elsevier; 2008: 58.
29. Sharathkumar A Pipe S. Pediatrics in Review 2008; 1:
121.
30. Saxonhouse M & Sola-Visner M. Current Issues in the
Pathogenesis, Diagnosis, and Treatment of Neonatal
Thrombocytopenia. In: Hematology, Immunology and
Infectious Disease: Neonatalogy Questions and Controver-
sies. Ohls R, Yoder M, eds. Vol. 1. Philadelphia: Saunders
Elsevier; 2008: 11.
The authors
Matthew A Saxonhouse, MD (a) and Martha C
Sola-Visner, MD (b)
(a)
Assistant Professor: Division of Neonatology,
Department of Pediatrics, University of Florida
College of Medicine, Gainesville, FL, USA
(b)
Assistant Professor of Pediatrics, Division of
Newborn Medicine, Children’s Hospital Boston and
Harvard University School of Medicine, Boston,
MA, USA.
Corresponding author for proof and reprints:
(a)

the management of neonatal haemorrhagic and
TE emergencies forces neonatologists to base their
medical decisions on limited evidence from case
reports and expert opinions. The ultimate goal is to
treat effectively without causing additional harm.
This can be difficult when treatments for both
haemorrhage and thrombosis have significant risks,
17. O’Grady NP et al. Pediatrics. 2002; 110: e51. Matthew A Saxonhouse, MD
18. Greenway A et al. Blood Rev 2004; 18: 75. Division of Neonatology,
19. Cartwright DW. Arch Dis Child Fetal Neonatal Ed Department of Pediatrics, PO Box 100296, 1600 SW
2004; 89: F504. Archer Rd., Gainesville, FL 32610, USA
20 Tardin FA et al. Arq Bras Cardiol 2007; 88: e121. Tel +1 352 392 4195 • e-mail : saxonma@peds.ufl.edu
21 Cholette JM et al. Ann Thorac Surg 2007; 84:1320.
22. Lau KK et al. Pediatrics 2007; 120: e1278. Coauthor address:
(b)

which need to be balanced against the benefits of 23. Wu YW et al. Ann Neurol 2003; 54: 123. Martha C Sola-Visner, MD
Division of Newborn Medicine,
Absolute Contraindications Relative Contraindications Children’s Hospital Boston and Harvard Medical
1. Central nervous system surgery or ischemia (including birth 1. Platelet count < 50,000/µl
School, 300 Longwood Ave, Enders Research Build-
asphyxia within ten days) 2. P latelet count <100,000/µl in neonate on mechanical ventilation, presence of ing, Rm. #961, Boston, MA 02115, USA
2. Active bleeding chest tubes, other risks for potential hemorrhage Tel + 1 617 919 4845
3. Invasive procedure within three days 3. Fibrinogen concentration < 100mg/dl e-mail: Martha.Sola-Visner@childrens.harvard.edu
4. Seizures within 48 hours 4. INR > 2
5. Severe coagulation deficiency
6. Hypertension Comments on this article?
Feel free to post them at
Table 5. Contraindications to thrombolytic therapy. Rules should also be applied to anticoagulation
www.ihe-online.com/comment/neonatal_coagulation
therapy but clinical judgment recommended.
 MInimally invasive surgery 11
NOTES-LESS radical prostatectomy
NOTES (natural orifice trans-endoluminal surgery) and LESS (laparo-endoscopic
single site surgery) have recently received considerable attention as a possible next
step in delivering effective operative treatment with reduced morbidity compared
to conventional surgical procedures. This article presents the latest advances in the
use of the technique for laparoscopic radical prostatectomy (LRP) in patients with
localised prostate cancer.
by Dr Eric Barret, Dr Rafael Sanchez-Salas and Dr John Watson
Ever since the original work of Walsh and to be the case, and since the initial introduc-
Donker, radical prostatectomy (RP) has been the tion of LRP, it has gradually evolved into a more
gold standard for the surgical treatment of local- established procedure.
ised prostate cancer [1]. Since then, the recent
accurate description of the dorsal vein complex, In 1998, our team of surgeons at the Institut
the pelvic plexus and cavernous nerves and pel- Montsouris hospital in the south of Paris began
vic fascia has had a significant impact not only carrying out LRP using a technique (now known
on the number of patients who are operated as the Montsouris technique) that we developed
on for prostate cancer, but also on the morbid- ourselves. Although the starting LRP technique
ity and mortality of the procedure itself [2]. In itself was well standardised, changes were gradu-
addition, this recent work has stimulated further ally introduced as a result of the natural evolu-
scientific investigation into the whole question tion of surgical performance and experience [4].
of prostatic carcinoma. During this period of change and development
there was however always a constant aim, namely
It was as early as 1997 that Schuessler et al to meet the demanding oncological and func-
described the first laparoscopic radical pros- tional objectives, while minimising the invasive
tatectomy (LRP) operation [3]. Although they nature of the procedure. As part of this process
initially considered the technique as conferring of optimisation of surgical performance, we have
no benefits compared to open surgery, they did recently begun using LESS-NOTES surgery.
however envisage that technical advances and NOTES (natural orifice trans-endoluminal sur-
the gradual accrual of practical experience could gery) and LESS (laparo-endoscopic single site sur-
improve the outcome. This indeed turned out gery) have recently received considerable atten-
tion as potential next steps in the quest to deliver
effective treatment with decreased morbidity.
This article describes the various advances that
have been made in our LRP technique, which is
now at a stage where we consider that our steep
learning curve has finally reached a plateau.
Development phases of
NOTES-LESS RP
The development of NOTES-LESS radical prosta-
tectomy has involved purely experimental phases,
purely clinical phases and transitional procedures
between the two. In the experimental phase, a
group from the Cleveland Clinic described robot-
assisted LESS radical prostatectomy in two human
cadavers using a transvesical approach [5]. The
first case used four closely grouped trocars, while
the second case involved the use of a single port
device. While some slight technical difficulty
was noted with the single port method (princi-
pally, clashing of the robotic arms), this approach
has the clear advantage of avoiding the need to
close multiple entry sites into the bladder. In
Figure 1. Trocar placement during Laparo-Endoscopic
Single Site surgery for Robot-Assisted Radical general, the articulated robotic instruments greatly
Prostactectomy (LESS-RARP). facilitated the complex manoeuvres needed for
– Issue N°3 – June 2009
vesico-urethral anastomosis and bladder closure.
Our team had previously described a tran-
sitional approach to NOTES-LESS radical
prostatectomy which involved initial experi-
mental work in a cadaver model, followed by
a transfer of the technique, this time using a
robotic interface, into a human patient [6]. In
the experimental procedure we used standard
laparoscopic ports around a single umbilical
incision, with an additional 5-mm port placed
in the right lower abdomen for suction and
countertraction, as well as a drain placement.
The robotics used in the clinical procedure
were standard, commercially available systems.
Despite some instrument clashes that made
exchanging robotic instruments somewhat dif-
ficult, in general the outcome was positive, with
a total operative time of only 150 minutes. We
have recently reported our first clinical proce-
dure using a complete LESS-robot-assisted rad-
ical prostatectomy (LESS-RARP) and no need
for extra ports. The procedure was successful,
with a change in port triangulation being key
to the success [7].
Several other studies have described LESS
prostatectomies in the clinical field. Kaouk
et al. completed four LESS radical prostate-
ctomies using a Uni-X port at the umbilicus
(U-LESS), and specially designed flexible shaft
laparoscopic instruments [8]. After dividing
the bladder neck, the surgical team found it
difficult to maintain adequate traction to dis-
sect the seminal vesicals; they therefore pro-
ceeded to the apical dissection and completed
the surgery in a retrograde manner. Anasto-
motic sutures were tied extracorporeally, and
tightened with a knot-pusher. There were no
interoperative complications, although one
patient developed a recto-urethral fistula two
months postoperatively.
Just as in the experimental procedures, the use
of robotic technology has been found extremely
useful in the clinical LESS procedures. For exam-
ple, Kaouk et al. carried out a radical prostatec-
tomy, a dismembered pyeloplasty and a radial
nephrectomy using U-LESS placement of the da
Vinci robotic system available from the US-based
company Intuitive Surgical, Inc. The procedures
were carried out without additional ports or
instruments; no complications were reported [9].
The future of
NOTES-LESS prostatectomy
The introduction of NOTES into urological prac-
tice was described by Gettman et al in 2002, who
described transvaginal nephrectomies in pigs
[10]. It was not until five years later that the first
 – Issue N°3 – June 2009 12 MInimally invasive surgery

publication on the clinical application of the
technique to radical prostatectomy appeared.
Although the LESS-NOTES development in
surgery has been widely adopted by the uro-
logical community over the last few years, only
referral centres for laparoscopic urological sur-
gery have reported such an application of the
LESS-NOTES approaches to LRP. In this appli-
cation, the use of robot systems helps greatly
in the carrying out of the surgical procedure,
thanks to the improved mobility provided by
the “Endowrist” technology of the da Vinci
robot system. For the moment there have only
been a few reports in the literature describing
the application of LESS-NOTES to LRP; these
reports generally compare the procedure with
other laparoscopic urological operations such
as adrenalectomies or nephrectomies. The rea-
son for the relative scarcity of papers describing
the use of LESS-NOTES to LRP is that radical
prostatectomy is still a challenging procedure
that has to be carried out by experienced sur-
geons to achieve optimum results. The potential
advantages of performing LESS-NOTES radical
prostatectomies on a routine basis is stimulat-
ing engineers and companies to develop new
instruments and devices designed to satisfy
the needs of surgeons. This trend will certainly
have a significant effect on the future evolu-
tion of the procedure. As for us, our current
intentions and objectives are to continue to
develop our technique and contribute to its more
widespread adoption by providing training and
mentoring for surgical teams who want to start
carrying out LESS-NOTES urological proce-
dures.With ongoing refinement of the technique,
and continued development of instrumenta-
tion, we hope that LESS-NOTES prostatecto-
mies will soon no longer be confined to a few
academic centres, but will be a key technique
in the general armoury available to the whole
urological community.
References
1. Walsh PC, Donker PJ. Impotence following radical
prostatectomy: insight into etiology and prevention.
J Urol 1982; 128(3): 492.
2. Walsh PC. The discovery of the cavernous nerves
and development of nerve sparing radical retropubic
prostatectomy. J Urol 2007; 177(5): 1632.
3. Schuessler WW, Schulam PG, Clayman RV, Kavoussi
LR. Laparoscopic radical prostatectomy: initial short
term experience. Urology 1997; 50: 854.
4. Guillonneau B, Vallancien G. Laparoscopic radi-
cal prostatectomy: the Montsouris technique. J Urol
2000; 163: 1643.
5. Desai MM, Aron M, Berger A, Canes D, Stein R, Haber
GP, Kamoi K, Crouzet S, Sotelo R, Gill IS. Transvesi-
cal robotic radical prostatectomy. BJU Int 2008; 102
(11): 1666-9.
6. Barret E, Sanchez-Salas R, Kasraeian A, Benoist
N, Ganatra A, Cathelineau X, Rozet F, Galiano M,
Vallancien G. A Transition to Laparoendoscopic
Single-Site Surgery (LESS) Radical Prostatectomy:
Human Cadaver Experimental and Initial Clinical
Experience. J Endourol 2009 Jan 2.
7. B
 arret E, Sanchez-Salas R, Cathelineau X, Rozet F,
Galiano M, Vallancien G. Initial complete laparoen-
doscopic single-site surgery robotic assisted radical
prostatectomy(LESS-RARP). Int Braz J Urol 2009;
35(1): 92-3.
8. K
 aouk JH, Goel RK, Haber GP, Crouzet S, Desai MM,
Gill IS. Single-port laparoscopic radical prostatec-
tomy. Urology 2008; 72(6): 1190-3.
9. K
 aouk JH, Goel RK, Haber GP, Crouzet S, Stein RJ.
Robotic single-port transumbilical surgery in humans:
initial report. BJU Int 2009;103(3): 366-9.
10. G ettman MT, Lotan Y, Napper CA, Cadeddu JA.
Transvaginal laparoscopic nephrectomy: develop-
ment and feasibility in the porcine model. Urology
2002; 59(3): 446-50.
The authors
Dr Eric Barret, Dr Rafael Sanchez-Salas,
Dr John Watson
Department of Urology Institut Montsouris
42 boulevard Jourdan 75014 Paris, France
eric.barret@imm.fr
Comments on this article?
Feel free to post them at
www.ihe-online.com/comment/LESSNOTES

Prostate cancer immunotherapy significantly prolongs
survival in men with advanced prostate cancer
Sipuleucel-T (Provenge),
an experimental immu-
notherapy, improved sur-
vival in men with meta-
static disease according
to new results to be pre-
sented at the American
Urological Association
(AUA) Annual Scien-
tific Meeting in Chicago.
These data from the
Phase 3 Immunotherapy for Prostate AdenoCarcinoma Treatment
(IMPACT) study were presented during the meeting’s Late Breaking
Science Forum.
Compared to placebo, sipuleucel-T extended median survival by 4.1
months and improved three-year survival by 38 percent. Sipuleucel-T
successfully exceeded the pre-specified level of statistical significance
defined by the study’s design and reduced the overall risk of death by
22.5 percent compared to placebo (p-value=0.032). Researchers are
encouraged by the findings, citing an impressive effect on long-term
survival for patients, compared to placebo. The ability to boost sur-
vival for patients is of course the gold standard endpoint in prostate
cancer clinical trials.
Sipuleucel-T is an investigational therapy for men with androgen-
independent prostate cancer. It is an active cellular immunotherapy
designed to use live human cells to boost a patient’s immune system
to elicit a long-lasting response against cancer.
http://www.aua2009.org/program/lba/lba9.pdf
Robotic approach to ureteral cancer of the kidney
proves to be beneficial for patients
Robotic trained surgeons at Fox Chase Cancer
Center in Philadelphia, USA presented a novel
approach to the surgical treatment of ureteral
cancer. Using da Vinci robot-assisted technol-
ogy, urological cancer surgeons performed
complicated operations using minimally inva-
sive surgery. Standard treatment for ureteral
cancer is either distal ureterectomy or nephro-
ureterectomy. Depending on the experience of
the surgeon, this procedure can be performed
using open surgery, while others may elect a
laparoscopic approach. In either instance, the surgeon’s experience is vital
for preserving function of the kidney.
A minimally invasive approach to this procedure is challenging for
even the most experienced laparoscopist because of the technical chal-
lenge of re-implanting the ureter into the bladder. Robotic assistance
can make a minimally invasive approach more technically feasible. In a
video abstract, the Fox Chase urological cancer surgeons demonstrate the
four-arm technique for robot assisted distal ureterectomy. In the video,
a robotic distal ureterectomy is performed on a 73-year-old man with
a distal left ureteral tumour. During the surgery, the four robotic arms
and two assistant ports were successfully positioned in a manner simi-
lar to robot assisted radical prostatectomy. This approach resulted in the
usual benefits associated with minimally invasive surgeries, such as less
bleeding and scarring, shorter hospital stay, faster recovery and return to
normal activity and with kidney function preserved.
http://www.urosource.com/home/today-s-key-article/key-articles/view/
article/robotic-assisted-kidney-cancer-surgery-beneficial-for-patients/
 Minimally invasive surgery 13 – Issue N°3 – June 2009

LARS in adult patients: does it have a

place in the definitive treatment of GERD?
With Laparoscopic Anti-Reflux Surgery (LARS) substituting for open surgery to treat reflux, traction, which is one cause of dysphagia. Addi-
surgical therapy with new standards has now become a valid alternative to medical ther- tional technical options, such as the construc-
apy for adult patients with Gastroesophageal Reflux Disease (GERD). Improvements in tion of complete (360º) vs. partial (240º or 270º
) wraps depending on the existence of preopera-
preoperative evaluation, together with routine physiological studies and better detection of
tive motility disturbances, seem to vary between
the failures of medical treatment now allow physicians to appropriately select patients for centres. Some authors do not accept that poor
surgery. The high therapeutic success rates, low levels of surgical complications and side peristalsis should be considered as a contrain-
effects, mean that LARS is a realistic alternative for the definitive treatment of GERD. dication of a full 360° wrap [11, 12], provided
that the above principles have been met, and
by Dr R. Garcia-Gallont that the wrap is applied as a “floppy” fundop-
lication. If, however, the surgeon decides to
perform a partial wrap with an esophagus with
The diagnostic and therapeutic options avail- the long-term results obtained with medical or very poor motility, long term results show an
able for patients with Gastroesophogeal Reflux surgical approaches are similar, but that overall patient satisfaction of 90% after five
Disease (GERD) have significantly expanded there is a far lower complication rate with a years or longer [13].
over the past two decades. Not only has a Laparoscopic Anti -Reflux Surgery (LARS)
deeper physiological understanding of the procedure [3]. Side-effects
“GERD-complex” allowed the establishment Possible side-effects of LARS, such as dysphagia
of improved clinical pictures of acid reflux, One study which compared PPI-based medical and gas bloating with the inability to belch,
biliary and mixed reflux, and extra-esophageal treatment with LARS found after seven years may, in experienced hands, appear as infre-
or atypical symptoms among others, but it has of follow-up that there was “high” satisfaction quently as 9% and 2% respectively, and even
also enabled the full chracterisation of the with PPI therapy in only 60% of patients, com- then mainly involve patients with high BMIs,
pathological implications and premalignant pared to 82% in the LARS group. Moreover, in severely reduced esophageal motility, advanced
consequences of ongoing reflux (e.g. Barretts this study, 58% of the patients in the PPI group age and other particular characteristics. On the
esophagus). Although proton pump inhibitors chose to change to the LARS group before com- other hand, recurrence of symptoms, and even
(PPIs) and prokinetics provide a good stand- pletion of the observation period, raising their the reinstigation of acid-suppressing medica-
ard of treatment for the symptoms of GERD, satisfaction score to 85% [4]. Another study tion (ASMs), must be carefully re-evaluated,
the low pressure levels of the lower esophageal of the treatment of GERD with laparoscopic possibly together with new physiological tests,
sphincter (LES) mean that very long-term (or Nissen fundoplication showed that there was such as oesophageal pH-metry or MII to deter-
even permanent) medication may be necessary. 96% relief of symptoms after a 2-year follow mine if there is still acid reflux. Several studies
This can result in problems with patient com- up period [5]. Yet other studies demonstrate have described the ill-advised use of ASM in up
pliance and satisfaction, as well as the possi- the superiority of LARS over PPI therapy after to 50% of the patients, who were taking ASM to
ble occurence of side effects and the unknown up to seven years of follow up [6, 7], with the treat the “recurrence” of symptoms after surgery.
consequences of permanent acid suppression. best results being achieved in endoscopically- The authors conclude that symptoms alone are a
Additional information gained from the rou- proven erosive esophagitis. GERD with atypi- poor indicator of reflux status in cases of “recur-
tine application of physiological studies such as cal or extraesophageal symptoms, however, is rence” after LARS, and that further evaluation is
esophageal manometry have also documented normally resolved or improved in only 50-70% neceassary in these cases [14, 15].
the progressive deterioration of the complex of patients [8, 9]. Nevertheless a recent collabo-
swallowing mechanism in longstanding GERD, rative randomised trial carried out in the UK
even in the presence of standard medical ther- concluded that in this group of patients at 12
apy. It is an unfortunate fact that reflux into months follow up, LARS significantly improved
the esophagus persists despite therapy with health — as measured by GERD reflux scores
PPIs [1]. However, modern diagnostic tools and other general health status measurements
such as Multichannel Intraluminal Impedance — compared to medical treatment [10].
(MII) now allow the detection of such patients
even when they are receiving the best standard Much of the success of LARS depends, of course,
medical treatment [2]. on the particular technique employed; certain
basic procedures must be able to be carried out
Surgery or Medication? routinely. These include complete abdominal
All of the above facts have resulted in a revival mobilisation of the esophagus with reduction
of interest in the potential role of antireflux of the hiatal hernia, creation of an ample retro-
surgery for GERD. This has been enhanced by esophageal “window” to accommodate a wrap
the fact that, since the 90s, the surgical proce- without compression, careful preservation of
dure itself has changed from a complex open the vagal nerves and full mobilisation of the
surgical procedure into a video-laparoscopic gastric fundus, possibly with transection of the
procedure. Several studies have shown that short gastric vessels as a routine to avoid spiral Gastroscopic view of a Nissen wrap.
 – Issue N°3 – June 2009 14 Minimally invasive surgery

Surgical failure due to wrap loosening, dehis-
cence, herniation and telescoping-slippage, are,
taken together, reported in only 5% of cases,
although such problems are, of course, challeng-
ing and require surgical experience and spe-
cial skills. Under optimal conditions, surgery for
these cases can be performed laparoscopically, but
the threshold for operating on these cases using
open surgery should be very low, to avoid poten-
tially dangerous damage resulting from extremely
difficult dissections.
The coexistence of Barrett´s epithelium (BE)
together with longstanding reflux makes routine
endoscopy indispensable in all such patients,
and the question of whether the progression (or
regression) of BE could be influenced by LARS
is still unanswered. It appears that if LARS is
followed by a demonstrable rise of pH in the
distal esophagus, showing that pathological
exposure to acid has ceased, BE may undergo
regression of metaplasia and even of low-grade
dysplasia. This has been demonstrated in cer-
tain patients. In any case careful endoscopic
follow-up is necessary, since prevention of the
development of adenocarcinoma arising from
BE as a result of LARS has not been observed
systematically [16].
In conclusion, in the long term the use of LARS
for the treatment of GERD has been shown
to result in more effective symptom relief in a
higher percentage of patients, and to improve
the quality of life for these patients as compared
to the taking of long-term medication, even
with the best standard of care PPIs. Patient com-
pliance, adhesion to treatment, long term effects
of acid suppression and pharmacological side
effects or drug interactions should all be assessed
and compared with the low complication rates,
low incidence of side effects and good long term
results reported after LARS. Finally if costs are
considered, surgery is surely more cost-effective 11. B
 ooth MI, Stratford J, Jones L. Randomized clini-
than long-term full dose medication with PPIs cal trial of laparoscopic total (Nissen) vs. posterior
and prokinetic drugs. partial (Toupet) fundoplication for GERD based
on preoperative oesophageal manometry: Br J Sur
References 2008;95:57-63.
1. Becker V, Bajbouj M, Waller K et al. Aliment Pharma-  atti MG, Robinson T, Galvani C et al. Total fundop-
12. P
col Ther 2003; 26:1355-60. lication is superior to partial fundoplication even
2. M aine I, Tutuian R, Aggrawal A. Combined multichan- when esophageal peristalsis is weak. J Am Coll Surg
nel intraluminal impedance (MII) pH-monitoring to 2004;198:863-70.
select patients with persistent GORD for lap-Nissen  ngstrom C, Lonroth H, Mardani J et al. An ante-
13. E
fundoplication. Br J Surg 2006; 93 (issue12):1483-87. rior or posterior approach to partial fundoplication?
3. Violette A, Velanovich V. Quality of life convergence of Long term results of a randomized trial: World J Surg
laparoscopic and open antireflux surgery for GERD. 2007;31:1221-1225.
Dis Esophagus 2007;20:416-19.  alvani C, Fisichella PM, Gordoner MV et al. Symp-
14. G
4. M ehta S, Bennett J, Mahon D et al. Prospective Trial toms are a poor indicator of reflux status after fun-
of laparoscopic Nissen fundoplication vs. PPI ther- doplication for GERD: role of esophageal function
apy for GERD: 7-year follow up. J Gastrointest Surg tests: Arch Surg 2003;138: 514-519.
2006;10:1312-1317. 15. Bonatti H, Bammer T, Achem SR et al. Use of acid-
5. P eters JH, DeMeester TR, Crookes P et al. The treat- suppressive- medications after LARS: prevalence
ment of GERDwith laparoscopic Nissen fundoplica- of clinical indications: Dig Dis Science 2007;52:
tion. Prospective evaluation of 100 patients with “typi- 267-272.
cal” symptoms. Ann Surg 1998;228:40-50. 16. Garcia-Gallont R. Laparoscopic fundoplication
6. Lundell L, Miettinen P, Myrvold H et al. 7-year follow up for GERD: Are we there yet? Dig Dis 2008;26:
of a randomized trial comparing PPI with surgical ther- 304-308.
apy for reflux esophagitis. Br J Surg 2007;94:198-203.
7. Mahon D, Rhodes M, Decadt B et al. Randomized The author
clinical trial of laparoscopic Nissen fundoplication Rudolf Garcia-Gallont MD
compared with PPI for treatment of GERD: Br J Surg Head, Dept. of Surgery
2005;92:695-699. AMEDESGUA-HOSPITAL
8. Vakil N, van Zanten SV, Kahrilas P et al. The Mon- Guatemala City, Guatemala
treal definition and classification of GERD: a global
evidence-based consensus. Am Jour Gastroenterol Address for correspondence:
2006;101:1900-1920. Dr. Rudolf Garcia-Gallont
9. K aufmann JA, Houghland JE, Quiroga E et al. Long- 6 ave 7-39 Zone 10
term outcomes of laparoscopic antireflux surgery Edificio Las Brisas, of. 206
for GERD-related airway disorders. Surg Endosc Guatemala City, Guatemala.
2006;20:1824-1830. e-mail: garciagallont@hotmail.com
10. G  rant AM, Wileman SM, Ramsay CR et al. Minimal
access surgery compared with medical manage-
ment for chronic gatro-oesophageal reflux disease:
Comments on this article?
Feel free to post them at
UK collaborative randomized trial. BMJ 2008;337:
www.ihe-online.com/comment/GERD
2664-2671.

Linked angina relates with gastroesophageal by physicians if the diagnostic necessity arose. Patients with ECG signs of
reflux diseases? coronary artery ischaemia were defined as ST segment depression based on
the Minnesota code.
It is well known that non-cardiac chest Among 712 patients (36%) with GERD, ECG was performed in 171 (24%),
pain is closely related to gastroesopha- and ischaemic changes were detected in eight (5%). Four (50%) of these lat-
geal reflux diseases (GERD). Chest pain ter patients with abnormal findings upon ECG had no chest symptoms such
of esophageal origin can be difficult to as chest pain, chest oppression or palpitations. These patients (0.6%; 4/712)
distinguish from that caused by cardiac were thought to have non-GERD heartburn, which may be related to ischae-
ischaemia because the distal esophagus mic heart disease. Of the 281 patients who underwent ECG and did not have
and the heart share a common afferent GERD symptoms, 20 (7%) had abnormal findings upon ECG. In patients
vagal supply, and GERD can cause epi- with GERD symptoms and ECG signs of coronary artery ischaemia, the
sodes of non-cardiac chest pain that resemble ischaemic cardiac pain. prevalence of linked angina was considered to be 0.4% (8/1970 patients).
A research team led by Dr Yoshihisa Urita from Toho University School The study results suggest that an extra-oesophageal condition causes GERD
of Medicine, Japan, investigated the association between GERD and coro- symptoms, and that angina may be misclassified as GERD. Since patients with
nary heart diseases; the study was published recently in the World Journal GERD have an increased risk of angina pectoris in the year after GERD diag-
of Gastroenterology. The study involved 1970 consecutive patients. All of nosis, physicians should be to be concerned about missing clinically impor-
the patients who first attended their hospital were asked to respond to the tant coronary artery disease while evaluating patients for GERD symptoms.
F-scale questionnaire regardless of their chief complaints. All patients had a
careful history taken, and a resting echocardiography (ECG) was performed www.wjgnet.com/
 Minimally invasive surgery 15 – Issue N°3 – June 2009

Transumbilical single port access

cholecystectomy (SPACE)
The technique of single port access (SPA) is as a recent devel-
opment resulting from the search for innovative approaches
in laparoscopic surgery. Through the use of a single incision,
there are fewer tissue lesions and access-related complica-
tions, as well a better cosmetic result. We describe here the
use of a commerically available system suitable for various
laparoscopic cholecystectomy operations and which allows
up to three instruments to be inserted simultaneously into the
abdominal cavity. A practically invisible scar results when the
the system is placed transumbilically.
Figure 1. The ASC TriPort in situ.

by Dr T. E. Langwieler and Dr M. Back
Patients and methods
Our team of surgeons were trained
in the technique with the help of a
Pulsating Organ Perfusion Model.
After we obtained institutional
review board (IRB) approval from
the ethical committee of the local
hospital, and informed patient
consent, we treated 36 patients by
laparoscopic cholecystectomy in
SPA surgery; one patient underwent
hemicolectomy. We used the ASC
TriPort system (from Advanced
Surgical Concepts, Dublin, Ireland)
which is a multichannel pathway
allowing two instruments and one
video laparoscope to enter simul-
taneously through only one inci-
sion. The system consists of vari-
ous components which assure the
retraction of the abdominal inci-
sion and maintenance of the cap-
noperitoneum during instrument
changes. Using the introducer, the
inner ring of the TriPort is inserted
through a transumbilical 2 cm long
laparotomy into the abdominal
cavity. The inner ring is connected
to two outer rings via a doubled
over cylindrical plastic sleeve. The
sleeve is then pulled outwards and
put under tension by drawing the
inner and the outer ring as close as
possible together. This tension cre-
ates a pathway for the laparoscopic
instruments through retracting of
the incision. One 12mm and two
5 mm gateways consisting of a
thermoplastic elastomer maintain
the capnoperitoneum during the
surgical procedure. We used a 5-mm
rigid 30° video-laparoscope (Endo-
Eye, Olympus Medical, Tokyo,
Japan), so we could also use 10mm
laparoscopic instruments such as
clips. After inserting the TriPort,
the subsequent steps were carried
out exactly like the usual two-win-
dow laparoscopic cholecystectomy
or laparoscopic hemicolectomy.
In no cases were any additional
incisions needed.
Results
All procedures were completed suc-
cessfully without any periopera-
tive complications, with all patients
being very satisfied with the cosmetic
result of a perfectly covered scar
within the umbilicus. Initially, the
time taken to carry out the opera-
tion was longer than for standard
laparoscopic cholecystectomy.
Discussion
The longer operative time was mainly
caused by the limited space, itself the
result of using only one access. This
meant that the instruments, the tel-
escope and the hands of both the
surgeon and assistant could easily
collide with each other. Such colli-
sions can be avoided through the use
of special instruments with curved
shafts, together with a semi flexible
endoscopic camera system (LTFVH,
Olympus), The SPA – technique is
a new, safe method for the carrying
out of laparoscopic surgery. By plac-
ing the system transumbilically, the
result is practically “scarless”. Fur-
thermore access-related injuries and
complications are probably reduced
by using one single incision.
Given our positive findings with the
system so far we are now using a
transumbilical placed trocar at the
start of every laparoscopic cholecys-
tectomy. After exploration, we pro-
ceed with either the SPA-technique
or standard laparscopic cholecys-
tectomy. We also intend to carry out
hemicolectomy procedures using the
SPA – technique.
Further Reading
1. Langwieler TE et al. Single-port access
in laparoscopic cholecystectomy. Surg
Endosc 2009; 23(5): 1138-41
2. Romanelli JR et al. Single Port Lapar-
oscopic Cholecystectomy with the
MAKE A CHOICE!
All can choose 中国制造... and you?
CHOOSE ITALIAN!
Medical Equipment Solutions
www.progettimedical.com
TriPort System: A Case Report. Surg
Innov 2008; 15(3): 223-28
 umbs AA et al. Totally Transumbili-
3. G
cal Laparoscopic Cholecystectomy. J
Gastrointest Surg 2008 Aug 16; [Epub
ahead of print]
 ao PP et al. The feasibility of single
4. R
port laparoscopic cholecystectomy: a
pilot study of 20 cases. HPB (Oxford)
2008; 10(5):336-40
The authors
Thomas E. Langwieler, MD and M.
Back, MD
Department of General and Visceral-
Surgery and Minimal-Invasive-
Surgery
Ev. Amalie Sieveking Krankenhaus
Ein Haus der Albertinen Gruppe
Haselkamp 33, 22359 Hamburg,
Germany
T.E.Langwieler@amalie.de
EPG6view
6Ch ECG
www.ihe-online.com & search 44953
 – Issue N°3 – June 2009 16 surgery

Innovation in surgery
Surgery plays a vital role in modern healthcare systems, with surgical procedures bloodstream are no longer the stuff of science
contributing significantly to the restoration of the health of many patients. Far from fiction: practical examples of surgery carried
being a static field, there is a vibrant development of innovative surgical tech- out by nanorobots already exist today, making
it possible, for example, to cut dendrites from
niques. This article describes the current roles of surgery and the huge likely impact
single neurons [6]. Micro-nanosurgery is thus
of the new surgical initiatives. The case is made for a more balanced approach a new field of research based on such micro-
in the current bio-tech dominated EU-sponsored research programmes so that sur- systems components, micro-robotic technolo-
gery research is given an increased role, commensurate with its huge potential to gies and sensors. For example, the objective of
improve the overall well-being of the population. the European VECTOR (Versatile Endoscopic
Capsule for gastrointestinal tumour recogni-
by Prof. N. Di Lorenzo, Dr L. Cenci, Eng. L. Iezzi, Dr V. Tognoni and Prof. A. L.Gaspari tion and therapy) project is to use micro and
nanotechnology to develop miniaturised, swal-
lowable robotic pills for advanced diagnostics
Research in surgery reacts to transplants in terms of rejection and therapy in the human digestive tract. The
By its very nature, research in surgery is an or acceptance. aim is a dramatic improvement in the early
interdisciplinary field, since it can incorporate • Heart and lung surgery: aggressive surgery in detection and treatment of gastrointestinal
technologies, tools and materials that may have lung resection and cardiac repair of congeni- cancers and cancer precursors [7].
not been initially intended for use in surgical tal and acquired diseases has been vital in the
procedures. The integration of surgical proce- study of cardiopulmonary physiology and the Minimally invasive surgery (MIS)
dures with other disciplines both within and development of extracorporeal circulation. This field has seen tremendous growth since the
outside the life sciences continues to be wide- • Prosthetics: the biocompatibility of a large first laparoscopic cholecystectomy was performed
spread and will become even more important number of prosthetic materials has been in 1985. Natural Orifice Translumenal Endoscopic
in years to come. definitively assessed as a result of their clini- Surgery (NOTES) is a recent development of MIS
cal use in cardiovascular, orthopaedic, otolog- and an area of intense interest; NOTES may offer
In several surgical fields, such integration has ical and general surgery. advantages over open and laparoscopic surgery
also increased scientific knowledge. Some • L aryngeal conservative surgery: the increas- [8]. The technique involves the use of endoscopic
examples are: ing spread of conservative, subtotal and laser instruments to access the peritoneal cavity in
• Neurosurgery: intra-operative monitoring of surgery has provided new insights into the order to carry out diagnostic and therapeutic pro-
neurosurgical procedures has facilitated the pathophysiology of swallowing. This has cedures. The benefits to the patient that NOTES
study and mapping of functions in different resulted in a dramatic development in reha- provides are the minimising of tissue trauma and
areas of the brain and the nervous system. While bilitation procedures for patients with head the reduction of postoperative pain and potential
under local anaesthesia, patients have been able injuries and ischaemia. wound complications, since the technique avoids
to describe their sensations and perceptions incisions in the abdominal wall. In MIS medical
during surgical procedures. NanoSurgery imaging technologies enable tracking of the pre-
• Intestinal surgery: surgical resection of gas- Advances in different sectors such as nano- cise location of surgical instruments and implants
trointestinal segments has led to the discovery technology, gene technology, and particu- in relation to multidimensional images of the
and understanding of complex gastrointestinal larly in regenerative medicine, robotics and patient’s anatomy.
hormonal patterns. information technology, have all resulted in
•T  ransplantation surgery: the development the development of completely new applica- e-Health
of organ transplantation has made it possi- tions. Nanorobots fitted with operating instru- A nation’s wealth and competitiveness depends
ble to study how the human immune system ments, and which are injected into the patient’s to a large extent on the good health of its citi-
zens. However it has to be recognised that there
is a large increase in mobility within Europe
not only of the population at large but also of
healthcare professionals (short- and long-term).
To meet the challenges posed by such changing
demographics, surgery, in particular, can benefit
from the advances in information and commu-
nication technologies to form the sector known
as e-Health. These innovative applications offer
numerous opportunities for cost reduction in the
healthcare sector, as well as improved data collec-
tion and increased information exchange. Com-
puters and related technologies have the poten-
tial not only to disseminate surgical innovations
but also to facilitate the development of novel
techniques and to allow surgeons to carry out
remote operations, share information or record
The European VECTOR project is using micro and nanotechnology to develop miniaturised, swallowable their results. Mobility in surgery can thus be both
robotic pills for advanced diagnostics and therapy in the human digestive tract. physical and virtual.

EU sponsored research
In spite of the large number of surgical procedures
carried out every year and the importance of sur-
gery for the overall well-being of European citi-
zens, the importance of surgery is unfortunately
not reflected by EU policies and funding pro-
grammes. For example, the current EU Seventh
Framework Programme for Research and Devel-
opment (FP7) does not include surgery as a top
priority in its agenda. A look at the topics listed in
the FP7 work programme for health shows clearly
that the focus is mostly on projects linked to
biomedical topics and research to improve drug
development. A search of FP7 using the terms
“surgery” and “surgical” results in only 25 unique
projects currently being conducted that involve
surgery. What is even more surprising is that only
four of these projects are within the work pro-
gramme for health — the majority of the projects
are being carried out in the field of information
and communication technologies (ICT), with
most of them being exclusively focused on new
imaging systems and virtual simulation.
Thus even a superficial examination of the
projects currently being financed under FP7
makes it clear that there is an urgent need
for a more balanced approach in EU fund-
ing policies, so that surgery can take its
rightful place.
For these reasons, experts in the field are call-
ing for support for pure surgical R&D so that
numerous applications can be developed and
brought into use even if the applications may
not be marketable per se. Globally there are
many manufactures of surgical instrumenta-
tion, as well as private institutions, that carry
out specific programmes to develop new tech-
niques and procedures that can then be mar-
keted. However, such a purely market-based
approach does not guarantee that necessary
basic research aimed at treating and improv-
ing specific health conditions, will actually be
carried out. This is simply because the surgi-
cal procedure itself may not be profitable on a
purely financial basis, despite its potential of
creating a huge improvement in the well-being
of the patient. This is precisely one more reason
why there is an urgent need to incorporate sur-
gical R&D into the European policy agenda and
research programmes.
Contrary to the largely biotechnology-focussed
research which the EU has funded for 30 years,
basic surgery research and its introduction into
clinical practice can bring a real improvement
for patients. If funding mechanisms continue
as they are currently defined the result will be
the introduction of new and ever more expen-
sive drugs, whose clinical impact is frequently
marginal or even negligible.
Surgical safety.
It is also important that the EU support surgi-
cal projects aimed at improving patient safety.
17 – Issue N°3 – June 2009
Examples of such projects are : 3. S copinaro N et al. A comparison of a personal series
• The need to register surgical interventions in a of biliopancreatic diversion and literature data on
systematic and standardised way is now essen- gastric bypass help to explain the mechanisms of
tial. Technology can play a very important role resolution of type 2 diabetes by the two operations.
by recording the nature of the operations and Obes Surgery 2008;18:1035.
enabling practitioners around the world not 4. R ubino F, Gagner M. Potential of surgery for cur-
only to learn but also correct their techniques, ing Type 2 diabetes mellitus, Annals of Surgery.
and so improve their results. Using this type of 2002;236:554.
information to develop procedural standards 5. M ason EE et al. A decade of change in obesity sur-
will help to reduce errors, allow a better curric- gery, Obesity Surgery 1997; 7:189.
ulum and portfolio for surgeons in training to 6. Freitas RA Jr. Nanotechnology, nanomedicine and
be designed, and reduce learning time. Moni- nanosurgery, International Journal of Surgery
toring and standardisation are therefore essen- 2005; 3: 243.
tial in order to promote patient safety, increase 7. www.vector-project.com
success rates and prevent disease. 8. www.noscar.org
• Clinical trials will, of course, play a very impor- 9. Coscarella G, Iezzi L, Di Lorenzo N, Cenci L, Tognoni
tant role in ensuring that new surgical proce- V, Gaspari AL. Patient safety: Prevention of acciden-
dures and devices can be safely used in patients. tal burns in laparoscopic surgery. 1st European Meet-
Currently in Europe, most of the clinical trials in ing of Young Surgeons June 18-20 2009 Campus
surgery are carried out privately and financed by Biometico of Rome.
the very same companies that have developed
the product or technique. This can lead to a lack The authors
of credibility, and some of these trials have been Prof. Nicola Di Lorenzo,
moved to independent auditing bodies, mostly Aggregate Professor of General Surgery
based in the US. If Europe wants to remain com- Dr Livia Cenci, Eng. Luca Iezzi,
petitive in the field of surgical innovation, new DrValeria Tognon, Prof. Achille L.Gaspari
mechanisms to conduct surgical clinical trials Department of Surgical Sciences,
must be put into place. Università di Roma Tor Vergata
viale Oxford 8100133
Training and education Rome,
Technology requires constant training and Italy.
updating of skills, so the development of new
surgical training systems and methodologies is
a key facet of effectiveness. Simulation systems,
for example, have been developed as useful
tools to ensure surgeons have the required skills
before commencing a clinical research project,
and to avoid practicing on patients, which is an
ethical concern. The regular use of such tools
can become part of a systematic approach to
innovative surgical education, which is very
much in need of standardisation and harmo-
nisation in different countries. Regulation of
these new learning tools is necessary. Such a
major effort for the education of future genera-
tions of European surgeons, finally leading to
increased patient safety, must be supported by
the European Institutions.
In conclusion, surgery is still a cornerstone
in maintaining the health of European citi-
zens. There is a need for a more sensitive atti-
tude from the European Parliament and Com-
mission. To summarise, surgery needs more
financial support!
References
1. Weiser T et al. An estimation of the global volume
of surgery: a modelling strategy based on available
data. The Lancet 2008;372:139.
2. Scopinaro N et al. Specific effects of biliopancreatic
diversion on the major components of metabolic
syndrome: a long-term follow-up study. Diabetes
Care 2005; 28:2406. www.ihe-online.com & search 44935
 – Issue N°3 – June 2009 18
Computer-aided intra-operative US
navigation in minimally invasive urology
With its advantages of real-time results, non-invasiveness and ease of handling Ultra
Sound (US) is currently the most widely-used system for intra-operative imaging.
Recent advances in computer-aided digital technology, such as the fusion of US with
CT/MRI, and “augmented reality navigation”, are providing new opportunities to
improve precision in urological intervention and surgery.
by Dr Osamu Ukimura
In minimally invasive surgery (MIS), the surgeon
inevitably has a lower level of tactile contact with
the patient than with classical open surgery. It is
therefore especially crucial in MIS procedures that
the surgeon is able to track precisely the position of
surgical instruments and that their anatomical ori-
entation is displayed. This challenge is being met
by image-guided surgery, a growing field that is
becoming increasingly adopted not only by experi-
enced surgeons to improve their precision but also
to facilitate the training of novice surgeons. Such
surgical navigation systems provide useful intra-
operative anatomical and/or pathological informa-
tion in addition to what the surgeon can actually
see, thus compensating for the initial disadvantages
inherent to the minimally invasive approach.
During surgical operations, in addition to actu-
ally seeing the patient, the surgeon must rely on
anatomical knowledge, CT, US or MRI images
and biopsy/pathology reports, all of which should
have been obtained before the operation. In con-
trast, intra-operative US provides real-time ana-
tomical and pathological information, which can
enhance intra-operative decision-making. Thus,
there is a clear difference between the roles of
‘intra-operative real-time imaging navigation’ and
‘pre-operative image screening by US or CT/MRI’.
The distinction between real-time intra-operative
imaging and images obtained pre-operatively is
blurred, since intra-operative US navigation can
now incorporate previously obtained pre-operative
knowledge and real-time surgical information.
Laparoscopic radical
prostatectomy (LRP)
Recently, we reported our experience of carry-
ing out energy-free nerve-sparing laparoscopic
radical prostatectomy (LRP) using intra-operative
real-time transrectal ultrasound (TRUS) to moni-
tor the operative procedure [1-4]. Combined with
prior knowledge of biopsy-proven cancer loca-
tion, such real-time TRUS monitoring during LRP
enables individualised, precise dissection that is tai-
lored to the specific prostate contour anatomy, thus
achieving a significant decrease in the incidence of
positive surgical margins [3]. In particular, precise
UltraSound
intra-operative knowledge of the presence, location
and degree of microscopic extra-prostatic exten-
sion of cancer could potentially allow the surgeon
to modify the surgical dissection by performing a
site-specific, slightly wider excision at the “high-risk
area” of the extra-prostatic extension of the cancer to
secure negative margins, while still achieving partial
nerve preservation. When comparing two groups
of patients undergoing LRP with or without intra-
operative TRUS, we found a significantly decreased
rate of positive surgical margins in patients with
stage pT3a disease (18% vs. 57%, respectively;
p<0.002) [3].
Intra-operative US guidance has thus been shown
to have advanatages in urology. However, it should
always be realised that conventional intra-opera-
tive real-time US guidance requires significant
expertise in technical performance and interpre-
tation. This may be the reason behind reports that
intra-operative real-time US is less reliable than CT
in the interpretation of renal pathology, and less
reliable than MRI in showing prostate pathology.
Furthermore, conventional intra-operative real-
time US has the shortcoming of providing only a
2D image, and so requires imagination on the part
of the surgeon to understand the 3D anatomical
relationships surrounding the surgical target.
Fusion of real-time US
and CT/MRI
Recent advances in digital compu-
ter technology are providing new
opportunities to improve surgical
planning, urological intervention
and intra-operative navigation.
Thus, fusion of real-time US with
pre-operative CT/MRI is now
possible [5, 6]. Three dimen-
sional US images are generated
by acquiring a series of adjacent
2D US images. Even 4D US imag-
ing is now available which can
show a dynamic 3D image with
coronal, axial and sagittal planes
on a display simultaneously in Figure 1. Schematic diagram of the principles of fusion of real-time US and
real-time [7]. More recently, we CT/MRI (Real-time Virtual Sonography).
have been the first to introduce overlaid 3D image-
guided navigation (which we call augmented real-
ity navigation) for use during various laparoscopic
urological surgeries [8, 9].
Recently, we have introduced a new computerised
digital US technology, namely a fusion system of
real-time US with preoperative CT/MRI images,
which we use to show renal pathology during per-
cutaneous intervention [5]. This system, which fuses
US and CT/MRI data, has the potential to enhance
the precision of urological interventions such as
renal intervention and prostate targeted biopsy or
intervention, and compensates for the limitations of
US with synchronised high-resolution CT or MRI
images; these latter are reconstructed from volume
data and displayed in parallel on the same screen as
the US image. The precision of the ablative area can
be confirmed from its overlap on the synchronised
image of the renal/prostate tumour on reformat-
ted CT or MRI. Importantly, since enhanced CT or
MRI images are available as the reconstructed fused
image, the need for repeated contrast enhancement
during the treatment procedure is also reduced.
This novel hybrid imaging technology is expected to
facilitate more precise needle placement, and more
precise monitoring of the ablative area while reduc-
ing the radiation exposure compared to repeated
use of CT guidance systems alone.
Augmented reality navigation
Overlaid 3D image-guided navigation (augmented
reality) was initially applied to neurosurgery appli-
cations, which have a relatively fixed small space,
frames and a bony reference, which facilitate the
registration of virtual and real images [10, 11].
Augmented reality navigation enables surgeons to
make direct interpretation of 3D imaging beyond

Figure 2. Augmented reality (3D US image overlaid onto the real surgical endoscopic view).
the surgical view; the 3D images are superim-
posed onto the real surgical view. This powerful,
new, intra-operative navigation technology allows
the merging of computer graphics and real surgi-
cal imagery into a single, coherent perception of
the enhanced surgical world around the surgeon.
The application of augmented reality in individual
clinical settings will offer enhanced realism, poten-
tially not only improving precision in surgery that
is difficult even for the expert surgeon, but also
decreasing the learning curve for the novice by
minimising adverse effects. In our initial experi-
ence of laparoscopic radical prostatectomy using
augmented reality navigation as described above,
intra-operative real-time TRUS was carried out
and the 3D motion of the TRUS probes was fol-
lowed with the aid of an optical tracking system
which measured the position of the optical markers
attached to the probes [8,9]. The regions of interest
containing the prostate and biopsy-proven hypo-
echoic cancer lesion were defined, thus enabling
the creation and development of a surgical plan-
ning 3D model of the prostate and cancer area by
the volume rendering method. Since the US image
is real-time, and thus available at any time point
during the surgery, the constructed 3D geometry
can be projected very precisely without the need
for a registration process, and can be updated at
any time point during the surgery. The prostate,
biopsy-proven cancer area and neuro-vascular
bundles are finally superimposed in accordance
with the 3D coordinates onto a real video image of
the laparoscopic surgical field. Our development
of real-time intra-operative TRUS-guided LRP
was an important step forward, resulting in a sig-
nificant improvement in positive surgical margin
rates [1-4]. Although the procedure was successful,
it should be realised that it is a difficult procedure,
as the presence of the real-time TRUS and laparo-
scopic images on different video screens requires
the laparoscopic surgeon to continually synchro-
nise mentally the two images while operating. An
ideal situation would be to precisely determine
the locations in three dimensions of the prostate,
prostate cancer nodule, neuro-vascular bundles
19
and other relevant pelvic tissues, and superimpose
3D images of those tissues onto the intra-opera-
tive laparoscopic view of the surgery, which could
then guide appropriate modification of surgical
resection. This ideal situation has been realised in
practice by our development of augmented reality
navigation technology. US is the most attractive
for surgical navigation because intra-operative US
is real-time and the 3D model can be updated at
any time point during the surgery.
Conclusion
Intra-operative US assistance beyond the endo-
scopic surgical view has the potential to increase
the precision of urological interventions during
minimally invasive surgery, providing preopera-
tive oncological data and a better understanding
of the surrounding vital anatomies. Novel dig-
ital computer technologies, such as the fusion of
real-time US with CT/MRI, as well as overlaid
3D-image navigation, potentially improve both
oncological and functional outcomes in mini-
mally invasive urology.
References
1. Ukimura O, Gill IS, Desai MM, Steinberg AP, Kilciler M,
Ng CS et al. Real-time transrectal ultrasonography during
laparoscopic radical prostatectomy. J Urol 2004;172: 112.
2. Gill IS, Ukimura O, Rubinstein M, Finelli A, Moinzadeh
A, Singh D et al. Lateral pedicle control during laparo-
scopic radical prostatectomy: refined technique. Urology
2005; 65: 23.
3. Ukimura O, Magi-Galluzzi C, and Gill IS. Real-time tran-
srectal ultrasound guidance during nerve-sparing laparo-
scopic radical prostatectomy: Impact on surgical margins.
J Urol 2006;175: 1304.
4. Ukimura O and Gill IS. Pictorial essay: real-time tran-
srectal ultrasound guidance during nerve-sparing laparo-
scopic radical prostatectomy. J Urol 2006; 175: 1311.
5. Ukimura O et al. Real-time Virtual Sonographic Radi-
ofrequency Ablation of Renal Cell Carcinoma. BJU Int
2008; 101: 707.
6. Singh AK et al. Initial clinical experience with real-time
transrectal ultrasonography-magnetic resonance imaging
fusion-guided prostate biopsy. BJU Int 2008; 101: 841.
– Issue N°3 – June 2009
7. D olkart L, Harter M, Snyder M. Four-dimensional ultra-
sonographic guidance for invasive obstetric procedures. J
Ultrasound Med 2005; 24:1261.
8. Ukimura O and Gill IS. Imaging assisted endoscopic surgery
– Cleveland Clinic experience. J Endourol 2008; 22: 803.
9. Ukimura O, Gill IS. Image-fusion, augmented reality and
predictive surgical navigation. Urol Clin North Am 2009;
36: 115-123.
10. I seki H, Masutani Y, Iwahara M, Tanikawa T, Muragaki
Y, Taira T, Dohi T, Takakura K. Volumegraph (overlaid
three-dimensional image-guided navigation). Clinical
application of augmented reality in neurosurgery. Stere-
otact Funct Neurosurg 1997; 68:18-24.
11. M arescaux J, Rubino F, Arenas M, Mutter D, Soler L.
Augmented-reality-assisted laparoscopic adrenalectomy.
JAMA 2004; 292:2214-2215.
The author
Osamu Ukimura, MD, PhD
Associate Professor,
Department of Urology
Kyoto Prefectural University of Medicine
Kawaramachi-Hirokoji,
Kyoto 602-8566, Japan
e-mail: ukimura@koto.kpu-m.ac.jp
Global flagship reference
site opened
Medical imaging specialist Barco is further
expanding its clinical collaborator network
with a brand-new customer reference site at the
‘Dienst Medische Beeldvorming’, the radiology
practice serving the General Hospital Group AZ
Groeninge in Kortrijk, Belgium. With this ini-
tiative, Barco further intensifies its cooperation
with the clinical end-user community.
As a global reference site, the Medical Imaging
Department at the hospital has been equipped
with the very latest in diagnostic display tech-
nology, including the first 6 MegaPixel colour
display system for diagnostic imaging. In addi-
tion, the department has rolled out Barco’s
MediCal QAWeb solution for intervention-free
calibration, Quality Assurance and asset man-
agement throughout the enterprise. For Barco,
the agreement offers new opportunities to inter-
act directly with the clinical end-user commu-
nity, and enables them to analyse the use and
performance of medical displays in their natural,
clinical habitat. In addition it enables physicians
and clinical professionals from other hospitals
to see the imaging products in operation in a
real-world, high-volume clinical practice.
The new global reference site enables visiting
clinicians to evaluate high quality displays in their
natural, clinical habitat.
 – Issue N°3 – June 2009 20
Monitoring for endoleaks with CEUS after
endovascular aneurysm repair
Endoleaks are common following endovascular aneurysm repairs (EVAR) and
present a diagnostic challenge in the follow-up after EVAR. Contrast-enhanced
ultrasound (CEUS) is a promising new method for the diagnosis and post-operative
monitoring of endoleaks.
by Dr D-A Clevert
Although early and midterm results of endovas-
cular repair of abdominal aortic aneurysms
(AAA) are promising, long-term durability and
outcomes of this technique are still unclear.
AAA patients treated with stent grafts therefore
require lifelong surveillance to detect incomplete
sealing between the stent graft and the aortic
wall, with persistent aneurysm perfusion and a
risk of secondary rupture, according to the type
of endoleak [1, 2]. Recent articles have described
the use of contrast-enhanced ultrasound (CEUS)
for endoleak detection after aortic stent graft
repair [3-5]. Rapid advances in imaging tech-
niques combined with the development of a new
generation of contrast agents have improved this
clinical application of ultrasound. CEUS is a
relatively new, accurate, time- and cost-effective
and minimally invasive tool for the detection of
endoleaks after EVAR. In this review we describe
the use of CEUS in clinical practice to classify
and determine the importance of different types
of endoleaks.
Definition and aetiology
After successful endovascular aortic aneurysm
repair, approximately one third of patients
will suffer aneurysmal endoleaks with possible
Figure 1. Aortic aneurysm demonstrated by CEUS in
sagittal view with EVAR treatment (red arrows). CEUS
showing type IIA endoleak (yellow arrows) via the the
lumbar artery.
Ultrasound
expansion that is associated with an increased
risk of rupture [6-7]. These endoleaks, which are
a persistent communication between the aneu-
rysm sac and the systemic circulation, can be
caused by several mechanisms, the commonest
being the reversal of blood flow in aortic branch
vessels with a retrograde flow into the aneurysm
sac (type II endoleak) [8]. Currently the sig-
nificance of endoleaks and their relationship to
aneurysm enlargement and rupture is a topic of
discussion [9-10]. It is logical that patients with
complex relevant anatomies should be more
prone to suffer endoleaks. Short, angulated,
ulcerated, trapezoidal and thrombus-containing
necks pose a challenge when constructing a seal
between the stent graft and the native vessel.
There is some evidence that some patients are at
higher risk than others of developing collateral
endoleaks [11].
CEUS technique
Technical developments over the past decade
have focused on different microbubble (MB) con-
tents and effective methods for detecting their
nonlinear signals. For instance, a low mechani-
cal index (MI 0.15-0.19) allows real-time gray-
scale imaging [12]. Contrast-specific techniques
apply a low acoustic pressure to produce images
based on nonlinear acoustic interaction between
the ultrasound system and stabilised MBs. These
MBs oscillate and resonate, giving continuous
contrast enhancement on gray-scale images [12].
The detection technique harnesses nonlinear MB
energy discovered within the same fundamen-
tal frequency band as the transmitted pulses of
sound, and thus offers improved sensitivity.
SonoVue is a second generation contrast agent
consisting of stabilised MBs of sulphur hexafluo-
ride gas, which are eliminated through the respi-
ratory system. The contrast agent is of low solubil-
ity, innocuous, isotonic with human plasma, and
devoid of antigenic potential, as it does not con-
tain any proteinaceous material [13]. The required
dose is still not well defined and depends on the
ultrasound system used. To improve contrast
enhancement detectability, the recommended
dose for a single injection is 0.8 to 1.2 mL [5, 13].
Classification of endoleaks
Endoleak Type I
If the flow into the aneurysm sac originates
from around a stent graft attachment site, it is
classified as type I. Some have suggested fur-
ther categorisation of type I endoleaks, namely
type IA (proximal) and type IB (distal). What-
ever the type, separation occurs between the
stent graft and the natural arterial wall, creat-
ing a direct communication with the systemic
arterial circulation [10, 14].
Endoleak Type II
Type II endoleaks are the most common type
of endoleak encountered after EVAR. Type
II endoleaks represent retrograde blood flow
through aortic branch vessels into the aneurysm
sac. They occur when blood travels through
the branches from the unstented portion of the
aorta or iliac arteries that anastomose with ves-
sels in direct communication with the aneurysm
sac [Figure 1]. Typical sources include the infe-
rior mesenteric and lumbar arteries and Riolan´s
anastomosis. Type II endoleaks are further subdi-
vided into a simple, single ingress and egress ves-
sel (Type II A) and complex, multiple feeding and
draining endoleak vessels (Type II B) [14].
Endoleak Type III
Type III endoleaks occur when there is a struc-
tural failure of the stent graft, such as stent-graft
fractures, or holes that develop in the fabric of
the device. In addition, this category includes
the junctional separations seen with modular
devices. Repetitive stress placed on the graft by
arterial pulsation can also cause these types of
leaks. As the aneurysm sac shrinks, additional
forces are applied to the graft which in time
can result in graft failure. Although currently,
type III endoleaks are rare, they will probably
become more prevalent as stent grafts begin to
age and there is more long-term follow-up of
these patients [14]. Recently, the occurrence of
microleaks has been described as another cause
of type III endoleaks. These have been demon-
strated remote from the stent-graft insertion
with expanding aneurysm sacs. Microleaks are
thought to be caused by multiple factors, includ-
ing holes due to broken sutures and failure of
thin-walled stent-graft fabric related to balloon
dilation and systemic pulsatile pressures.
Endoleak Type IV:
Endoleaks that are caused by graft wall porosity
are classified as type IV. These leaks are identified
at the time of implantation as a “blush” seen dur-
ing the immediate post-implantation angiogram,
 21 – Issue N°3 – June 2009

when patients are fully anticoagulated. Such endoleaks require no specific

intervention except normalisation of the coagulation profile.

Endoleak Type V
Endotension was originally defined as expansion of the aneurysm sac
after successful endovascular repair of an abdominal aortic aneurysm.
The term has now evolved to describe tension exerted on the aneurysm
wall with or without the presence of an endoleak. Some physicians refer
to endotension as a type V endoleak [10]. The exact cause of endotension
is unknown.

Discussion
Currently ultrasound technology offers promising developments such as
CEUS, which is a noninvasive, rapid, well-tolerated, reproducible and
apparently very sensitive imaging modality [15-16]. In our experience the
use of a sonographic contrast agent increases the sensitivity of the ultra-
sound examination and improves the detectability of endoleaks. None-
theless, CEUS has some limitations. Obesity and bowel gas can interfere
with US scanning, and patient compliance is always required. The equip-
ment, including the contrast agent, is highly specific and not yet widely
available; it is also expensive. Personnel performing the examination
require specific skills and training. Finally, CEUS may be very sensitive
for evaluating per graft flow, but is not appropriate for the evaluation of
other factors such as graft anchorage and integrity, and changes in aneu-
rysm morphology; here computed tomography angiography (CTA) is the
modality of choice [17]. However, CTA has some limitations, such as
potential contrast agent allergy and nephrotoxicity, radiation exposure
and cost. Furthermore CTA is affected by metallic artefacts. In theory,
CEUS is more reliable than CTA for the identification and classification
of endoleaks [18].

Conclusion
Contrast-enhanced ultrasound enables the detection and evaluation of
endoleaks after EVAR. In our interdisciplinary ultrasound centre, CEUS has
become an important additional diagnostic tool to follow up patients after
EVAR, and might become the modality of choice in the future.

References
1. White RA. J Endovasc Ther 2000; 7: 522.
2. Cuypers P et al. Eur J Vasc Endovasc Surg 1999; 17: 507.
3. Clevert DA et al. Cardiovasc Intervent Radiol 2007; 30: 480.
4. Clevert DA et al. Eur Radiol 2007; 17: 2991.
5. Napoli V et al. Radiology 2004; 233: 217.
6. Baum RA et al. Radiology 2000; 215: 409.
7. Baum RA et al. J Vasc Surg 2001; 33: 32.
8. Maldonado T, Gagne PJ. Vascular and Endovascular Surgery 2003; 37: 1.
9. Wolf M et al. J Vasc Surg 2002; 36: 305.
10. Veith FJ et al. J Vasc Surg 2002; 35:1029.
11. Velazquez OC et al. J Vasc Surg 2000; 32: 77.
12. Bauer A et al. Academic Radiology 2002; 9: S282.
13.Greis C. European Radiology 2004;14: Suppl 8: 11.
14. Stavropoulos SW, Charagundla SR. Radiology 2007; 243: 641.
15. Clevert DA et al. Clin Hemorheol Microcirc 2008; 39: 171.
16. Clevert DA et al. Clin Hemorheol Microcirc 2008; 39:133.
17. Thurnher S, Cejna M. Radiologic clinics of North America 2002; 40: 799.
18. Clevert DA et al. Clin Hemorheol Microcirc 2008; 40: 267.

The author
Dr DA Clevert, Associate Professor of Radiology,
Department of Clinical Radiology,
University of Munich – Grosshadern Campus,
Marchioninistr. 15,
1377 Munich, Germany.
Tel: +49 89 7095 3620
 – Issue N°3 – June 2009 22
Patients with high BMI need
more aggressive bowel
preparation before colonoscopy
Obesity is an independent predictor of inadequate
bowel preparation at colonoscopy, and the pres-
ence of additional risk factors further increases the
likelihood of a poorly cleansed colon, according
to a new study in Clinical Gastroenterology and
Hepatology, the official journal of the American
Gastroenterological Association (AGA) Institute.
Since the majority of colon cancers arise from ade-
nomatous (benign) colon polyps, proper screen-
ing becomes crucial while performing colonos-
copy on obese patients. An inadequately cleansed
colon can jeopardise the effectiveness of screen-
ing or surveillance colonoscopy, exposing these
patients at higher risk for colorectal tumours to
the dangers of missed lesions and higher cost of
repeat colonoscopy.
In this study, believed to be the first of its kind,
patients were designated overweight when BMI
was ≥25 and obese when ≥30. Bowel prepara-
tion was assigned a unique composite outcome
score that took into account a subjective bowel
preparation score, earlier recommendation for
follow-up colonoscopy due to inadequate bowel
preparation and the endoscopist’s confidence in
adequate evaluation of the colon. A high BMI
(≥25) was associated with an inadequate com-
posite outcome score. In multivariate logistic
regression analyses, both BMI ≥25 and ≥30 were
retained as independent predictors of inad-
equate bowel preparation. Each unit increase in
BMI increased the likelihood of an inadequate
composite outcome score by 2.1 percent.
http://www.redorbit.com
Second strokes often follow within
hours of minor strokes
About half of all peo-
ple who have a major
stroke following a
warning stroke (a tran-
sient ischaemic attack
or mild stroke) have it
within 24 hours of the
first event, accord-
ing to research led by
Dr Peter Rothwell,
University of Oxford,
UK. For the study,
researchers analysed
the medical records
NEWS IN BRIEF
of 1,247 people who experienced a TIA, or minor
stroke. Of those, 35 had recurrent strokes within
24 hours during the first month after experiencing
the TIA. Scientists looked at whether patients had
another stroke within six, 12 and 24 hours after
the first stroke. The timeline started when the
person either experienced symptoms of a stroke
or first called for medical help. The study found
that after six hours, the risk of a second stroke
went up by 1.2 percent. After 12 hours, the risk
climbed another percent and by 24 hours the risk
increased to five percent.
Dr Rothwell said that this was the first rigorous
population based study of the risk of a second
stroke within 24 hours of a minor stroke. The sec-
ond stroke rate was about five percent, with half
of all second strokes within seven days occur-
ring in the first 24 hours, and half of these early
recurrent strokes being disabling or fatal.
http://www.aan.com/
Surgery proves effective in
treating paediatric obstructive
sleep apnea
Infants and young toddlers with obstructive
sleep apnea and sleep disordered breathing
experience significant improvement following
surgical treatment of the ailment, according to
an article in Otolaryngology-Head and Neck
Surgery. Sleep disordered breathing (SDB) in
children, from infancy through puberty, while
similar to adult sleep apnea, actually has dif-
ferent causes, consequences and treatments. A
child with SDB does not necessarily have this
condition when they become an adult. The con-
sequences of paediatric obstructive sleep apnea
include snoring; sleep deprivation (which can
cause moodiness and behavioural issues);
abnormal urine production; slowed growth and
development; and attention deficit and atten-
tion deficit hyperactivity disorders.
The study evaluated 73 cases in which children
younger than two years old were treated for
obstructive sleep apnea through the removal of
the adenoids, tonsils, or both (adenotonsillec-
tomy). Those treated through surgery experienced
significant improvement on the apnea-hypopnea
index (AHI), an index that measures the sever-
ity of sleep apnea. Those treated medically, but
not surgically, exhibited no improvement after
treatment. The study’s authors also concluded that
the rate and types of post-surgical complications
were within acceptable levels.
http://www.generef.com/
Obesity and diabetes double risk
of heart failure
The twin epidemics of obesity and type 2 diabetes
will continue to fuel an explosion in heart failure,
already the world’s most prevalent chronic cardi-
ovascular disease, according to John McMurray,
professor of cardiology at the Western Infirmary,
Glasgow, UK. He reported that around one-third
of patients with heart failure have evidence of dia-
betes, and the outlook for them is very serious.
Effective treatment is “very difficult”. Obesity, like
diabetes, is increasing in prevalence. The latest
report from Euroaspire, Europe’s largest survey of
cardiovascular risk factors in coronary patients,
found that the prevalence of obesity had increased
from 25 per cent in 1997 to 38 per cent in just ten
years — and this in people who had already had
at least one heart attack.
Professor McMurray said that obesity was
at least as great a risk factor for heart failure
as it was for heart attack or stroke, more than
doubling the risk.
The pathways by which obesity plays such a role
in heart failure are not yet fully understood, but
have been shown to have an indirect effect via
hypertension, or heart attack, or diabetes – and
a direct effect on the heart muscle itself. An even
more intriguing suggestion is that adipose cells
might act as an endocrine tissue, secreting sub-
stances which may have a harmful effect on heart
tissue and blood vessels.
The relationship between diabetes and heart
failure is also a subject of investigation, with the
risk of heart failure doubled in diabetics. Heart
failure patients with diabetes also have worse
symptoms, a higher risk of hospitalisation and a
greater risk of death than those without diabetes
– suggesting that the underlying pathophysiol-
ogy of heart failure may be different in diabet-
ics and non-diabetics. Professor McMurray also
notes an “intersection” of the two conditions by
which those with diabetes have a higher risk of
heart failure, and those with heart failure have a
higher risk of diabetes.
http://spo.escardio.org/
 Literature review
Hospital management
The number of peer-reviewed journals
covering hospital administration is huge,
and certainly too vast for managers to
keep up with. As a special service to
our readers, IHE presents a selection of
literature abstracts, chosen by our edito-
rial board as being particularly worthy
of attention.
Salary structures
Incentive payments to academic
anesthesiologists for late afternoon
work did not influence turnover times
Masursky D et al.
Anesth Analg. 2009 May;108(5):1622.
In many hospital set-ups, the system is that rates of
pay are increased for work that runs unexpectedly
late, e.g. into the late afternoon, early evening. The
suspicion was that some unscrupulous members
of hospital personnel might profit from such an
arrangement by deliberately making interventions
longer than really necessary. Although anesthesi-
ologists have little influence on their operating
room (OR) assignments and workloads late in the
afternoon, they can influence turnover times. In
this study of anesthesiologists, turnover times on
workdays were examined both before after and
incremental pay systems were introduced. It was
found that there was no significant effect of the
implementation or changes to the pay program
on the incidences of prolonged turnover times at
each of the studied times.. The results suggest that
hospital administrators, deans and other execu-
tives need not be especially concerned about dis-
incentives produced by methods of internal com-
pensation of anesthesiologists on highly visible
OR turnover times late in afternoons.
Healthcare policy
Stroke presentation and hospital
management: comparison of
neighbouring healthcare systems
with differing health policies
Crawford VL et al
Stroke 2009 Jun;40:2143.
Acute stroke care is shaped by healthcare policies.
Differing policies in similar populations allow for
assessment of policy impact on health and health-
care outcomes. The purpose of the study reported
in this paper was to compare stroke presenta-
tion and hospital care in two adjacent healthcare
systems, one in Northern Ireland and one in the
Republic of Ireland, with differing healthcare
23
policies. It was found that there were marked
regional contrasts evident for key aspects of hospi-
tal care. Northern Ireland performed significantly
better on 15 of 16 quality of care (Sentinel Audit)
items. Delivery on standards was significantly bet-
ter in Northern Ireland for early assessment, multi-
disciplinary review, medications review, and for
discharge-rehabilitation planning. Preadmission
prescription of advised cardiovascular medications
was similar between regions for anti-hypertensives
and anti-coagulants but significantly higher in
Northern Ireland for anti-platelets and lipid-reg-
ulating medication. Prescribing levels increased in
both regions but with significantly lower levels in
Northern Ireland for anti-hypertensives. Northern
Ireland patients were more functionally dependent
and less aphasic. It was concluded that in similar
neighbouring acute stroke populations, differing
healthcare policies were associated with signifi-
cant differences in processes of patient care. Policy
reform is an important tool in ensuring optimal
stroke care delivery.
Hospital Costs
Direct medical costs of adverse
events in Dutch hospitals
Hoonhout LH et al
MC Health Serv Res. 2009 9;9:27.
Up to now, costs attributable to adverse events
(AEs) and preventable AEs in the Netherlands
have been unknown. The authors assessed the
total direct medical costs associated with AEs
and preventable AEs in Dutch hospitals to gain
insight in opportunities for cost savings. Trained
nurses and physicians retrospectively reviewed
7,926 patient records in 21 hospitals. Addi-
tional patient information of 7,889 patients was
received from the Dutch registration of hospital
information. Direct medical costs attributable to
AEs were assessed by measuring excess length
of stay and additional medical procedures after
an AE occurred. Costs were valued using Dutch
standardised cost prices.
It was found that the annual direct medical costs
in Dutch hospitals were estimated to be a total
of e355 million for all AEs and e161 million for
preventable AEs in 2004. The total number of
hospital admissions in which a preventable AE
occurred was 30,000 (2.3% of all admissions) and
more than 300,000 (over 3% of all bed days) bed
days were attributable to preventable AEs in 2004.
Multi-level analysis showed that variance in direct
medical costs was not determined by differences
between hospitals or hospital departments. It
could be concluded that the estimates of the total
preventable direct medical costs of AEs indicate
– Issue N°3 – June 2009
that they form a substantial part (1%) of the
expenses of the national health care budget and
are of importance to hospital management. The
cost driver of the direct medical costs is the
excess length of stay (including readmissions)
in a hospital. Insight into which determinants
are associated with high preventable costs will
offer useful information for policymakers and
hospital management to determine starting
points for interventions to reduce the costs of
preventable AEs.
Out-patient versus operating theatre
Cost minimisation using clinic-based
treatment for common hand conditions
— a prospective economic analysis
Webb JA, Stothard J
Ann R Coll Surg Engl. 2009 Mar; 91: 135.
The purpose of the study described in this
paper was to compare the cost of treatment of
Dupuytren’s disease, ganglia and trigger digits in
the out-patient department with the operating
theatre. All patients seen in a new patient hand
clinic with a diagnosis of Dupuytren’s disease,
trigger digit or ganglion of the wrist or hand
requiring treatment were prospectively identified
over a six-month period. The numbers under-
going a procedure in the out-patient clinic or
theatre were recorded. Costings of theatre time
and out-patient time, as well as national tariff
income, were obtained from the hospital man-
agement.It was found that over the six-month
period, 80, 26, and 52 patients were treated with
regard to Dupuytren’s disease, ganglia and trig-
ger digits, respectively. Of these, 37, 23, and 44
were treated by an out-patient procedure, and 43,
3 and 8 underwent a formal operation. The total
cost of the out-patient procedures was calculated
at £1,560 over six months. To perform these as
formal operations would have cost £64,896. The
cost savings were, therefore, £63,336, or £126,672
per annum.
Hospital Staffing
The family-friendly hospital:
(how) does it work?
Heller AR, Heller SC
Anaesthesist. 2009 May 31. {epub ahead of print]
Although based on an analysis of the German sit-
uation, the conclusions of this study are applicable
to all of Western Europe. The authors predict a seri-
ous shortfall of appropriately skilled and expen-
sively trained personnel in the hospital, caused by
the incompatibility between professional duties
and family responsibilities. The answer, accord-
ing to the authors, is the development of family-
friendly hospital work environments. This article
discusses the necessity, opportunities and threads
of family-oriented hospital management, looking
at anaesthesia departments in particular.
 – Issue N°3 – June 2009
24 PRODUCT NEWS
Medical camera
Compact ultrasound system
There is a need for
ultrasound systems
with higher cost-effec-
tiveness, flexibility, ease
of use and functional-
ity. To meet this need,
Aloka have introduced
the ProSound 4 instru-
ment. This is a stand-
alone, black-and-white Capturing images at a high resolution (1280 x
system with the latest 1024), the Dr. Highscope multi-functional cam-
digital technologies for era system represents a new generation of medical
higher image quality. imaging. The DHS probe comes with either a 12 or
The system is compat- 18.5 mm lens; various accessories can be attached
ible with many probes to the probe making the instrument useful for sev-
to meet the needs of eral applications. With the correct attachment, the
diverse applications in probe can serve as a colposcope, rectoscope, der-
fields such as radiology, mascope and aotoscope. All attachments allow a
obstetrics/gynaecology, urology and surgery. zoom in/zoom out function. Captured images can
Advanced technologies originally developed be stored in a JPEG format or recorded videos can
for high-end models now allow high diagnos- stored in MPEG4 AVI format. The SD card has a
tic precision. The compact, lightweight system memory of 4GB which allows a picture capacity
permits ultrasound examinations at almost of over 15,000 pictures or 100 minutes of video
any location, from bedside to the examination time. The camera can be used for real-time imag-
room. Compatible with the measurement and ing by connection to a 19-inch monitor or LCD
reporting needs of many applications, this ver- monitor. Other functions of the unit include File
satile ultrasound system is designed with use- Management (Create, Modify, Delete Folder or
ful features and functions for routine exami- File), Multimedia player or Thumbnail Viewer (4,
nations, including digital image archiving, 9, 16, 25, 36). Images can be adjusted for bright-
a standard USB memory port, network con- ness, sharpness, saturation, contrast, exposure and
nectivity, and digital data export in DICOM, white balance. There is also a convenient RGB filter
JPEG, and BMP formats. for specific images.
Aloka Co., Ltd Sometech
Tokyo, Japan Seoul, Korea
www.ihe-online.com & search 45280 www.ihe-online.com & search 45281
Mobile electrocardiograph Washer-disinfector
DEKO 190 LC is designed for emptying, flush-
ing, cleaning and thermally disinfecting by steam
human waste containers intended for re-use.
These include portable sanitary pans, supports
for single-use bedpans, hospital wash bowls, urine
bottles and other reusable products for patient
care. The water pressure for washing is supplied
by a high powered 600L/min recirculation pump.
Designed for carrying out ECG examinations at the The washing spray patterns are delivered through
patient’s home as well as in health-care institutions, three rotating and seven fixed spray jets guaran-
the AsCARD Mr. Green2 is a high quality 1- and teeing contact with all surfaces and crevices of
3-channel, compact, mobile electrocardiograph with items with varying design. Detergent is dosed
LCD display. Maintenance of the unit is very simple, into the re-circulated wash water by a pump. The
and the modern alphanumeric keyboard facilitates
operation. Able to be operated in either manual or
automatic mode, the unit can be powered either
externally or by an internal battery with charger.
More than 50 examination results can be printed in
automatic mode.
Aspel SA
Zabierzow, Poland
www.ihe-online.com & search 45282
unique working principle facilitates cleaning and
steam disinfection of the entire system, includ-
ing wash chamber, water tank and outlet, with the
minimum use of water and energy. The disinfect-
ing steam is generated by a built-in unpressurised
boiler and run through the water tank, outlet and
internal pipework. A wide selection of disinfec-
tion temperatures and cycle setups ensure that all
pieces of equipment are reliably sterilised. Cycles
can be altered to meet almost any special require-
ment, though the standard requirements are met
with the fixed, tested and approved cycles pre-
programmed by the manufacturer. The 3-level
access code system protects any unauthorised
changes to the set parameters.
Franke
Naarajärvi, Finland
www.ihe-online.com & search 45283
Mobile surgical stretcher chair
Specifically designed for use from pre-op to post-
op without patient transfer, the TM5 mobile
surgical stretcher chair increases efficiency and
minimises the risk of injury. Precise motorised
positioning (chair to stretcher) is possible and
there is a very low profile articulating headpiece.
Powered by a high capacity quick-change battery
system that includes a wall mounted charging
station and a second high capacity battery, the
stretcher chair incorporates a wider and longer
(188 x 61 cm) patient surface and has a 226 kg
patient weight capacity to accommodate larger
patients more comfortably and safely. Available in
two height adjustment ranges, a 20 degree seat tilt
is offered in addition to full body Trendelenburg
and reverse Trendelenburg.
Novymed International BV
‘s-Hertogenbosch, The Netherlands
www.ihe-online.com & search 45284
Surgical gowns and drapes
The new range of surgical gowns, drapes and
packs from Kimberley Clark are designed to pro-
vide the operating room (OR) team with a wider
choice to select the appropriate level of protec-
tion to meet the demands of specific surgical
procedures as well as providing the flexibility to
meet financial stingencies. There are three lines
in the new range. These are the KC 100 line for
low to moderate fluid-intensive procedures and

the KC 200 range for
enhanced perform-
ance and protection
for moderate to high
fluid-intensive pro-
cedures. Finally, the
KC 300 line provides
protection for the
most invasive and
fluid-intensive pro-
cedures. This includes the innovative MicroCool
technology, a breathable impervious fabric, which
provides the highest level of protection against
blood strike-through and viral penetration, while
keeping the wearer cool and comfortable.
Kimberley Clark
Dallas, TX, USA
www.ihe-online.com & search 45293
Continuous wound infusion catheter
Continuous wound infusion is a technique that
uses a multi-holed catheter to deliver local anaes-
thetics or analgaesics directly into the wound for
post-operative pain relief. Continuous wound
infusion has been proven to provide effective post-
operative analgaesia in in-patients and patients
undergoing orthopaedic and thoracic surgical pro-
cedures as well as laparotomy, hernia repair and
C-section. The PAINfusor catheter from Baxter
has an advanced design and a range of 19 gauge
catheters to cover various incision lengths. The
catheters are radio-opaque to allow identification
of the multi-holed section, the distance from the
beginning of the section and tip identification.
Baxter Healthcare
Deerfield , IL, USA
www.ihe-online.com & search 45290
Multi-modality breast
imaging workstation
Productivity at many European medical imaging
facilities is hampered by the need to read full-field
PRODUCT NEWS 25
digital mammography (FFDM) exams on each
vendor’s proprietary workstation, and then switch
to additional workstations to review other types
of breast exams. Overcoming this problem, the
Kodak Carestream mammography workstation
enables diagnostic review of all breast imaging
exams (FFDM, ultrasound, MR, CR and others)
as well as all general radiology exams. The system
offers many time-saving features including user-
customisable hanging protocols and an eight-key
programmable mouse.
Carestream Health
Rochester, NY, USA
www.ihe-online.com & search 45286
Dual Energy CT instead of joint
aspiration for gout diagnosis
The most reliable method of diagnosing gout is
to aspirate the joint in order to obtain fluid to
verify the presence of monosodiumurate crys-
tals (uric acid). Up to now, computed tomogra-
phy (CT) has played only a limited role in the
evaluation of gout, since conventional CT sys-
tems cannot reliably verify deposits of uric acid.
However, a current study at the Vancouver Gen-
eral Hospital in Canada gives rise to speculation
that dual-energy computed tomography (DECT)
could radically change the management of this
disease. DECT enables fast, noninvasive exami-
nations and, based on initial evaluations, has the
potential to surpass the clinical examination in
terms of identifying subclinical disease. Inves-
tigations have confirmed the high sensitivity of
the DECT method in detecting uric acid depos-
its. The Canadian scientists used the SOMATOM
Definition computed tomography (CT scanner)
from Siemens for their investigation. This system
is the only CT scanner worldwide that features
two X-ray tubes capable of simultaneously pro-
ducing different energies. The leading investiga-
tor, Dr S Nicolaou said “DECT is a promising
new technique that can in a reliable, noninvasive
fashion confirm the presence of gout tophi sub-
clinically, provide information on the patient’s
disease burden and enable differentiation from
other diseases. This technique may be used for
monitoring treatment success and can be used
to resolve unclear cases.
Siemens
Munich, Germany
www.ihe-online.com & search 45291
– Issue N°3 – June 2009
Imaging morbidly obese patients
Imaging of morbidly obese patients presents
an array of challenges. Most detrimental is the
damage and down-time incurred when excessive
weight ruins expensive DR panels. Reina Imag-
ing’s DRP Weight Distributer protects DR panels
by evenly distributing the patient’s weight across
the surface. Installation is simple with the snap-on
design that attaches to any OEM DR panel.
Reina Imaging
Crystal Lake IL, USA
www.ihe-online.com & search 45289
Advanced NIRS - based regional
oximetry system
Designed for instantaneous signal acquisition,
improved accuracy and consistency during
cerebral monitoring, the recently introduced
Model 7600 Regional Oximetry System from
Nonin Medical offers real-time management
of cerebral oxygenation for patients at risk of
ischaemia. The new system incorporates the
company’s EQUANOX near-infrared spec-
troscopy (NIRS) regional oximetry technol-
ogy to measure the balance of oxygenated
and deoxygenated haemoglobin (HbO2 and
Hb) in the cerebral cortex. An innovative sen-
sor design effectively removes surface tissue
effects that can influence measurement accu-
racy — while three-wavelength technology
reduces the sensitivity to patient physiological
differences. These advances improve accuracy,
repeatability and efficiency by eliminating pos-
sible measurement variations resulting from
repositioning or replacing the sensor. The
accuracy of the EQUANOX technology has
been proven to be superior to conventional
NIRS cerebral oximetry in validation testing
carried out at at Duke University, Chapel Hill,
NC, USA.
Nonin Medical
Plymouth, MN, USA
www.ihe-online.com & search 45287
 – Issue N°3 – June 2009
26 PRODUCT NEWS

Patient monitor
The next generation PACS system Incorporating a 12.1 inch TFT display
with optional touch screen facilities and
capable of a maximum of eight wave-
forms, the new iPM 9800 patient moni-
tor from Mindray has been designed for
easy operation and navigation.
Compact and light weight, the new
monitor is capable of running for up
to 7.5 hours on lithium ion batter-
ies or up to three hours with lead-acid
batteries. The system can store up to 96 hours of graphic and tabular trends of
all parameters.

Mindray
Shenzhen, P.R. China
Agfa has combined its extensive expertise in the PACS field with www.ihe-online.com & search 45288
the latest technology achievements and leading industry-design
principles to deliver a single workflow-based system that will serv-
ice consumers both within and outside the walls of the facility. The High performance defibrillator
new IMPAX 6 is a web-deployable image and information manage- The DefiMonitor XD defibrillator from Metrax
ment solution, which will help streamline enterprise workflow and combines an instrument design that is compact
deliver increased efficiency and productivity to hospitals. And, when and tried and trusted in practice with the highest
combined with the Agfa’s Impax RIS and reporting solutions, IMPAX possible degree of safety. The system incorporates
6 will provide a consolidated view and centralised management of biphasic defibrillation technology that spares the
patient image and information data. By enabling easy digitisation of patient’s heart muscles. The impulse output gen-
workflow, streamlining study review, and improved reporting and erates a current-regulated defibrillation impulse,
results distribution, IMPAX 6 adapts to the user’s specific needs, by which eliminates damaging peak loads. Detailed
operating the way the user wants it to. With its intuitive design, PACS software functions and well-thought out hardware
administrators, radiologists, clinicians and referring physicians will are features of the system. The high-contrast Blue-mode TFT LC display pro-
quickly learn to harness the power of Agfa IMPAX to improve the vides optimum monitor viewing and the removable storage cards in the Defi-
delivery of healthcare. To reach higher efficiency and effectiveness monitor range can optionally be used to transfer all the recorded ECG data to
levels, IMPAX 6 is delivered with dedicated services. any commercially available PC or to simply archive the data. A voice recording
system is standard.
Agfa Healthcare
Mortsel, Belgium Metrax
www.ihe-online.com & search 45292 Rottweil, Germany
www.ihe-online.com & search 45285

Calendar of events
August 29 – September 2, 2009 October 28-31, 2009 Fax +32 2 555 4555 Fax +43 1 533 40 64 - 448
ESC Congress 2009 62nd CMEF Autumn 2009 e-mail: avl@intensive.be e-mail: communications@myESR.org
Barcelona, Spain New International Convention & Exposition Center, www.intensive.org http://myESR.org
Tel. +33 4 9294 7600 Chengdu, China
Fax +33 4 9294 7601 Tel. +86 10 6202 8899 ext 3825 January 25-28, 2010 March 9-12, 2010
e-mail: congress@escardio.com Fax +86 20 6235 9314 Arab Health 30th international Symposium on Intensive Care and
www.escardio.org e-mail: jin.liu2@ReedSinopharm.com Dubai, United Arab Emirates Emergency Medicine (ISICEM)
http://en.cmef.com.cn Tel. +971 4 3365161 Brussels, Belgium
September 16-18, 2009 Fax +971 4 3364021 Tel. +32 2 555 3631
Medical Fair Thailand 2009 November 18-21, 2009 www.arabhealthonline.com Fax +32 2 555 4555
Bangkok, Thailand MEDICA 2009 e-mail: avl@intensive.be
Tel. +65 6332 9620 Düsseldorf, Germany February 25-28, 2010 www.intensive.org
Fax +65 6332 9655 / 6337 4633 e-mail: info@medica.de Early Disease Detection and Prevention (EDDP)
e-mail: medicalfair-thailand@mda.com.sg www.medica.de conference 2010 June 16-19, 2010
www.medicalfair-thailand.com Munich, Germany World Congress of Cardiology Scientific Sessions 2010
November 29 – December 4, 2009 Tel. +41 22 5330 948 Featuring the 3rd International Conference on
October 11-14, 2009 RSNA 2009 Fax +41 22 5802 953 Women, Heart Disease and Stroke
ESICM 2009 Chicago, IL, USA e-mail: eddp2010@paragon-conventions.com Beijing, China
22nd Annual Congress of the European Society of http://rsna2009.rsna.org www.paragon-conventions.com/eddp2010/ e-mail: congress@worldheart.org
Intensive Care Medicine www.worldcardiocongress.org
Vienna, Austria December 11-13, 2009 February 26-28, 2010
Tel. +32 2 559 03 55 • Fax +32 2 527 00 62 Medifest’09 2010 First International Meeting on Cardiac Problems For more events see
e-mail: Vienna2009@esicm.org Pragati Maidan, New Delhi, India in Pregnancy (CPP) www.ihe-online.com/events/
www.esicm.org Tel. +91 11 3058 0444 / 3058 0777 Valencia, Spain
Fax +91 11 3058 1000 Tel. +41 22 5330948
October 20 – 23, 2009 e-mail: info@vantagetradefairs.com e-mail: secretariat@cpp2010.com
Medical Fair Brno Central Europe 2009 www.vantagemedifest.com/medifest_india www.CPP2010.com
Brno Exhibition Centre, Czech Republic Dates and descriptions of future events have
Tel. +420 541 152 818 December 13-16, 2009 March 4-8, 2010 been obtained from usually reliable official
Fax +420 541 153 063 Update on Hemodynamic Monitoring ECR 2010 industrial sources. IHE cannot be held respon-
e-mail: medicalfair@bvv.cz Rome, Italy Vienna, Austria sible for errors, changes or cancellations.
www.bvv.cz/medicalfair-gb Tel. +32 2 555 3631 Tel. +43 1 533 40 64 - 0
www.ihe-online.com & search 45226