The Channel - Cook Medical

The Channel
A COOK NeWs PuBLiCATiON
CA
CATiON
issue 2, 2008
inside this issue
i
LEADING
THE WAY
Cook Medical solidifies its role
as the preeminent, innovative
full-line supplier
With its history of innovations – such as Fusion, DomeTip
accessories, the EchoTip Ultra with High Definition Fine
Needle Aspiration and the largest selection of plastic stents
on the market – Cook Medical has long been recognized
as a leader in the field of biliary interventional endoscopy.
However, the company has also created some of the most
creative solutions for esophageal, colonic and general
GI problems, as well. And, now, with two innovative new
products, clinicians have even more options to help them
improve outcomes for their patients.
Forging partnerships
From its earliest beginnings, Cook had a simple philosophy
that it maintains to this day: Collaborate with clinicians
on their ideas and needs to enhance patient care and
then design products to fill those needs. And the more
clinicians the company collaborated with, the wider the
selection of products Cook created. That attitude has
made the company a pioneer in the design of devices
that range from sphincterotomes to stents to multiband ligators.
LEADING ThE WAY Continued on page 2
Ac
cAse
cA
se of biliAry stones
& AnAstomotic biliAry
stricture After liver
trAnsplAnt All Just in
one session
4
Dr priscillA
riscill mAgno proves
riscillA
7
Att you cAn
A
cA
c
An go home AgAin
thAt
enDoscopic mucosAl
resection - DiAgnostic &
therApeutic implicA
implicAtions
mplicAtions
mplicA
Ations
in bArrett’s esophAgus
8
whAt’s
At’s up Doc?
A
9
europeAn enDoscopists:
evolution is A breAkbreAkk
kthrough...
europeAn & u.s.
gAstroenterologists
Discuss “the evolution of
metA
et l stenting”
etA
metAl
10
12
A wth hDfnA
echotip ultrA
13
A new center for eus
teAching in frAnce
14
A DA
DAy of continuing
eDucAtion
eDucA
ucA
ucA
Ation
tion in Queens, ny
16
JeAn brihAy
Ay - A towering
A
figure in the worlD of
enDoscopy
17
mArshA
A Dryer remembereD
18
At A
A
Abcgn
bcgn Dinner
LEADING ThE WAY
Continued from page 1
For example, Cook’s Saeed Six-Shooter Multi-band Ligator, renowned for its
reliability, has been the market leader for well over a decade. This 4-, 6-, or 10-band
ligator, which exhibits clinically significant band retention, has an Opti-Vu® Barrel
for a wide, uninterrupted procedural view and is available in the widest range of
sizes to fit any endoscope.
Cook dramatically changed the way
EMR procedures are performed with the
Duette Endoscopic Mucosal Resection device.
With Duette, clinicians can perform simple ligation
and snare resection of superficial lesions and early
cancers in the upper GI tract, key to achieving positive
procedural results.
Fulfilling clinicians’ needs
Just as Fusion revolutionized biliary interventional endoscopy,
two remarkable new devices – the Evolution
Controlled Release Stent System and the
Hercules 3 Stage Balloon Dilator –
are doing the same for esophageal
and general GI intervention. With
these latest innovations, Cook
Medical’s mission is to become
the preeminent full-line accessory
supplier, providing an ever-widening
array of tools to meet the needs of
more and more GI clinicians, both in
the field and in centers of research.
Evolutionary control
Deploy
Specifically designed to give clinicians more procedural control, Evolution
represents an entirely new approach to esophageal stenting. The idea is that the
more control during procedures, the better the outcomes can be. The ergonomic
handle, which can be operated with one hand, features a unique trigger mechanism.
Each squeeze of the trigger deploys or recaptures the stent in precise increments.
A convenient Directional Button allows the clinician to shift between stent release
and retraction, and there is even a “point of no return” reference mark that alerts
the operator when stent recapture is no longer possible.
Recapture
The Evolution stent, constructed from a single woven Nitinol wire, is designed
to deliver optimal radial force for superb luminal patency of malignant strictures
and sealing of tracheoesophageal fistulas. The stent is coated, inside and out, with
bio-friendly silicone that can potentially reduce tumor ingrowth and food bolus
impaction. The proximal and distal flanges are uncoated to anchor the stent to
help lessen the risk of migration.
Throughout an Evolution stenting procedure, clinicians can track progress with
radiopaque markers located on the introducer and on the stent. Immediately after
the stent has been placed, there is still the option to reposition thanks to a “lasso”
loop on the proximal end which can be grasped with forceps.
Release
2
www.cookmedical.com
The Channel
Engineered for strength
In an effort to improve outcomes during esophageal dilation,
Cook developed the Hercules 3 Stage Balloon, the latest and
strongest FDA-cleared three-stage esophageal balloon dilator.
By delivering extraordinary strength at the stricture site, the Hercules
is setting a new standard for accurate, three-stage esophageal dilation.
A unique proprietary technology allows the Hercules to generate greater,
evenly distributed radial force to a stricture at the same or lower pressures
than all other staging balloon dilators currently on the market. This
exceptional dilating strength can deliver more effective dilating force to relieve
the patient’s dysphagia and may improve longer-term patency.
154% Greater Radial Force on Average
Mean Radial Force in Newtons
600
549.8 N
475.8 N
500
400
300
247.5 N
200
195.6 N
191.1 N
18 mm
19 mm
20 mm
2
3
4
4.5
6
6
100
99.6 N
p =<0.0001
n =10
0
COOK
Leading
Competitor
Inflation Pressures (ATMs)
To add efficiency to the procedure, Hercules allows rapid deflation with the simple
application of negative pressure. Even if balloon removal begins prior to complete
deflation, the balloon can easily be withdrawn into the endoscope.
The mission continues
As the field of gastroenterology
continues to grow, Cook will
continue striving to fulfill the
needs of all clinicians, fulfilling
its mission to lead the industry
i n t h e d e ve l o p m e n t o f t h e
market’s most complete array of GI
endoscopic accessories.
www.cookmedical.com
3
A Case of Biliary Stones and Anastomotic
Biliary Stricture After Liver Transplant:
All
Just
In
One Session
Introduction
Mario Traina
Marta Di Pisa
Department of Endoscopy,
Istituto Mediterraneo Trapianti e
Terapie ad Alta Specializzazione (IsMeTT)
Biliary complications after liver transplant are a very common and relevant problem 1
(8 – 50%). Untreated biliary complications are associated with a high rate of morbidity
and mortality. Magnetic resonance is an effective technique in the evaluation of
biliary complications 2, but endoscopic retrograde cholangiopancreatography (ERCP)
and percutaneous transhepatic cholangiography (PTC) remain the gold standard
for the therapeutic options (with successful results between 70 and 80%) 3, 4, 5.
Common biliary complications after liver transplant are leaks and strictures,
which are divided into anastomotic and non-anastomotic. Other less frequent
complications include stones, cuts and oddities 6, 7.
We report a case of biliary anastomotic stenosis and biliary stones after orthotopic
liver transplant (OLT) treated with a combined percutaneous radiologic and
endoscopic approach (rendezvous technique) and with the use of an electrokinetic
lithotriptor and Fusion system.
Case report
A 67-year-old male underwent OLT with a choledocho – choledocho anastomosis,
because of HCV related cirrhosis, in 2000. The transplant was complicated by renal
failure, solved with hemodialysis for one month, but no vascular abnormalities were
noted from the Doppler ultrasound examination. Five years later, recurrence of HCV
occurred. The patient was treated with antiviral therapy without success, and upon
endoscopic evaluation there was evidence of medium-sized esophageal varices.
Other co-morbid conditions include severe obesity, hypertension and previous
partial gastrectomy for ulcer. He was admitted because of reassessment of the
liver disease and occurrence of cholestasis with several episodes of cholangitis.
At the admission, physical examination showed severe obesity (> 30),
and no signs of hydro - saline retention. Laboratory data were the
following: AST/ALT 130/187 U/L (normal: 5-40/65 U/L), bilirubin tot/dir 26.46/19.69
mg/dl (0-1.5 mg/dL), alkaline phosphates 357 U/L (40-134 U/L), gamma – GT 1161
mg/l. A magnetic resonance cholangiography was not performed because of the
severe obesity; ERCP was planned under general anesthesia. The bile duct was
cannulated, showing a mild anastomotic stricture with a very tight angle. Above
the anastomotic stricture, there were multiple stones, and at the confluence,
mild intrahepatic biliary dilation was noted (Fig. 1). A guide wire was passed
through the stenosis, but because of the stones and the very tight angle of the
4
www.cookmedical.com
The Channel
stricture, it was impossible to pass a Dormia basket, Fogarty extraction balloon
or any other catheter. Due to these challenges, the ERCP was unsuccessful and a
PTC was planned and a 6.6 Fr external - internal biliary catheter was successfully
placed (Fig. 2).
In the following days, because of worsening jaundice (bilirubin tot/dir 34.22/28.78
mg/dl), a combined radiologic and endoscopic technique (rendezvous technique)
was performed. In the angiographic suite and under general anesthesia, the
patient was monitored continuously with electrocardiography, pulse oximeter
and automatic recording of blood pressure and pulse. Intravenous antibiotic
prophylaxis was performed before the procedure. After visualizing the biliary
tree, under fluoroscopic control, using an Amplatz guide wire to gain access, the
previously placed biliary drain was changed with a 7 Fr vascular introducer.
With electrokinetic lithotripsy, a ballistic lithotriptor which uses high-energy magnetic
fields, placed through the introducer, percutaneous lithotripsy was performed; then
the sphincterotomy was done (Fusion Pre-loaded OMNI-Tome 21, FS-OMNI-21-480,
Cook Endoscopy, Winston Salem, USA). An endoscopic balloon dilatation of the
anastomotic stricture was performed using an 8 mm balloon catheter (Fusion
Biliary Dilation balloon, FS-BDB-8x3, Cook Endoscopy, Winston Salem, USA) and,
at the same time, under endoscopic control, the stones were completely removed
with a Fogarty balloon (Fusion Extraction balloon, FS-8.5-12-15A, Cook Endoscopy,
Winston Salem, USA) (Fig. 3). A final cholangiogram showed no filling defects or any
stricture and, at the end of the procedure, an external – internal biliary drain (12
Fr) was placed. Two months after the procedure, the patient currently has a biliary
catheter in place, is asymptomatic, in good general condition and without signs
of cholestasis.
Figure 1
Discussion
Biliary complications after liver transplant are common and biliary stones represent
a small part of these 1, 2. In the majority of cases, ERCP alone is the best diagnostic
and therapeutic treatment with a successful result in 70 – 80% 3, 4, 5 and is a less
invasive procedure, although it has some important complications 8. Western
studies show the efficacy of percutaneous transhepatic choledochoscopy (PTHC)
and holmium:yttrium-aluminum-garnet (YAG) laser to remove biliary stones in
patients unable or unwilling to undergo endoscopic or surgical removal, but this
technique requires many sessions time and prolonged biliary access 9.
Figure 2
In our patient, endoscopic management was attempted as a first option but was
unsuccessful in placing a stent in the correct position and then removing the
stones because of the stenosis and the stones just above the stenosis. Also, PTC
was able to place an external – internal biliary catheter but failed to remove the
stones and solve the stenosis.
So, we thought to apply the combined radiologic and endoscopic procedure
(rendezvous technique), using the Fusion System, associated with the use of a
ballistic lithotriptor, to solve the problem. In this way, just in one session, we were
able to remove the stones and solve the stenosis; also, we tried to avoid surgery for
this patient because of three main reasons: severe obesity, presence of a cirrhotic
graft and previous surgery for gastric ulcer.
ALL JUST IN ONE SESSION
Continued on page 6
Figure 3
www.cookmedical.com
5
ALL JUST IN ONE SESSION
Continued from page 5
The rendezvous technique has been described in the treatment of
benign or malignant biliary obstruction, in traumatic bile duct
injury repair and in the treatment of large biliary leak in a liver
transplant recipient 10, 11 but, to our knowledge, this is the first
report about the use of this technique in treatment of biliary
stones and anastomotic stenosis post liver transplant, associated
to a ballistic lithotriptor.
In conclusion, rendezvous technique, associated with an
electrokinetic lithotriptor and the Fusion System, allowed us to use
all advanced techniques and devices in one session which required
less time. This technique is a feasible alternative for stone removal and
biliary stricture management, when prior endoscopic or PTC attempts of
removal of stones and stenting the biliary tree have failed. As a result, this
approach avoided a possible surgery that could have a higher risk of complications
for this kind of patient.
REFERENCES
1) Stratta RJ, Wood Rp, Langnas AN et al. Diagnosis and treatment of biliary tract complication after orthotopic
liver trasplantation. Surgery 1989; 106: 675-683
2) Boraschi P, Braccini G, Gigoni R, et al. Detection of biliary complications after orthotopic liver trasplantation
with MR chlangiography. Magn. Reson. Imaging 2001; 19: 1097-1105
3) Greif F, Bronsther OL, Van Thiel DH et al. The incidence, timing, and management of biliary tract complication
after orthotopic liver trasplantation. Ann. Surg 1994; 219: 40-45.
4) Pfau PR, Kochman MI, Lewis JD, et al. Endoscopic management of postoperative complication in orthotopic
liver trasplantation. Gastrointestinal Endoscopy 2000; 52: 55-65.
5) Thulavath PJ, Atassi T, Lee J, An endoscopiuc approach to biliary complications following orthotopic liver
trasplantation. Liver Int. 2003; 23: 156-162.
6) Ernst O, Sergent G, Mizrhai D et al. (1999) Biliary leaks: treatment by means of percutaneous transhepatic
biliary drainage. Radiology 211:345-348
7) Pasher A, Neuhaus P, Bile duct complication after liver trasplantation. Trasplant International 2005; 18:
627-642
8) Loperfido S, Angelini G, Benedetti G, et al. Major early complications from diagnostic and therapeutic ERCP:
a prospective multicenter study. Gastrointest Endosc 1998; 48: 1 – 10
9) Hazey JW, McCreary M, Guy G, Melvin WS. Efficacy of percutaneous treatment of biliary tract calculi using the
holmium:YAG laser. Surg Endosc. 2007 Jul;21(7):1180-3.
10) Aytekin C, Boyvat F, Yilmaz U et al. (2006) Use of the rendezvous technique in the treatment of anastomotic
distruption in a liver transplant recipient. Liver Transpl 12:1423-1426
11) Usefulness of the “rendezvous” technique in living related right liver donors with post-operative biliary
leakage from bile duct anastomosis. R. Miraglia; M. Traina; L. Maruzzelli; S. Caruso; M. Di Pisa; S. Gruttadauria; A.
Luca; B. Gridelli. Cardiovascular and Interventional Radiology 2008 (in press).
6
www.cookmedical.com
The Channel
Dr. Priscilla Magno
proves that
You Can
Go Home Again
A
fter completing her training in Advanced Therapeutic Endoscopy at Johns
Hopkins University School of Medicine in 2007, Dr. Priscilla Magno returned
home to San Juan, Puerto Rico. In doing so, she was going against a common
trend. Because of the island’s sometimes volatile government and economy, most
Puerto Rican physicians who attend universities in the U.S. for sub-specialty training
remain in the United States.
But Dr. Magno has an abiding love for the island. “Puerto Rico is my beautiful home
country,” she says. And, she also has an abiding love for her chosen career field. “I was
searching for an opportunity that would allow me to continue an academic career
in GI, to provide unique care (EUS and other endoscopic interventions) to cancer
patients and to develop a research career – all in my home country, where the fields
of therapeutic EUS and EUS-assisted NOTES were virtually nonexistent.”
She found that opportunity at the University of Puerto Rico Comprehensive
C a n c e r C e n t e r ( U P R CCC ) w h e n s h e b e c a m e a n I n t e r v e n t i o n a l
Gastroenterologist and Clinical Researcher. One of the Center’s goals
is to recruit young academicians and allow them to develop a formal research
career in cancer with the grants and guidance provided by local government as
well as the University of Texas M.D. Anderson Cancer Center, Houston, TX.
From left to right:
Sergey V. Kantsevoy,
Priscilla Magno, M.D. and
Samuel A. Giday (JHH) presenting at
the 2007 European Digestive Diseases
Congress in Paris
“Currently there are only about 40 interventional gastroenterologists on the island,
all in private practice, who perform routine ERCPs,” say Dr. Magno. “So far, I am the
only Puerto Rican therapeutic endoscopist who has completed two-year training
in EUS, ERCP and NOTES.* And, EUS is of paramount importance due to its clinical
impact in the management of gastrointestinal cancer.”
The University of Puerto Rico is the only tertiary care medical facility and trauma
center in the Caribbean with 24-hour expert surgical, medical and radiological
support. Dr. Magno is immediately seeking to practice EUS in Puerto Rico and then
to also serve those patients from the Caribbean and South America.
“One of the main benefits,” says Dr. Magno, “is that patients on the island and
other parts of the Caribbean will be receiving affordable and appropriate medical
care without the inconvenience of being so far away from home. This is of vital
importance for cancer patients who need support from their families. Having
a familiar health care provider and relatives during the moment of receiving a
diagnosis of cancer or the results of a failed therapy can help mitigate the difficult
pathway of what it means to have cancer and fight against cancer.”
Dr. Magno is happy to be home, practicing her career specialty and helping her
fellow islanders, but she hopes that this is only the beginning. “I received a warm
welcome from private gastroenterologists who were glad to see an EUS practice
and advanced therapeutic endoscopy services established in the island. But we’ve
got a long way to go.” The Cancer Center is creating an endoscopy unit with stateof-the-art equipment that will address the patient population adequately.
And Dr. Magno is looking even further ahead to hopefully keep Puerto Rican
clinicians at home: “My long-term objective is to start a EUS training program right
here on the island.”
* Since this article went to press, other EUS services are now available in Puerto Rico.
www.cookmedical.com
7
Endoscopic
Mucosal
Resection: Diagnostic and
Robert J. Korst, MD
Medical Director, The Blumenthal
Cancer Center
Director of Thoracic Surgery
Valley Health System/The Valley
Hospital
1 Valley Health Plaza
Paramus, NJ 07652
Therapeutic
Implications in
Barrett’s Esophagus
E
ndoscopic mucosal resection (EMR) is being performed with increasing
frequency in the esophagus. The use and adoption of this technology by many
endoscopists has been facilitated by the availability of the Duette multiband
mucosectomy kit. The advantages of the Duette system lie in the ability to perform
multiple resections without withdrawing the endoscope from the patient, as
well as the lack of need for a submucosal injection to lift the target lesion off the
muscular layer of the esophagus. As familiarity increases with this instrumentation,
the indications for its use in the esophagus are also expanding, especially in regard
to Barrett’s esophagus.
Diagnostic Implications
The obvious utility of EMR lies in the ability to completely resect small, endoscopically
visible lesions in the Barrett’s segment. Historically, such lesions were approached
with a standard biopsy forceps. The advantages of EMR over standard biopsy in
this circumstance are manyfold. First, many of these small lesions (1-1.5 cm) can be
removed in their entirety with EMR. Second, the EMR specimen allows for careful
pathologic assessment of margins. Third, if the lesion is malignant, the presence of
invasion can not only be assessed, but also the precise depth of invasion. Since the
depth of invasion as determined by EMR is evaluated histologically, it is far more
accurate than endoscopic ultrasonography for these early lesions.
EMR reproducibly removes the two inner layers of the esophageal wall, the mucosa
and submucosa. Since the submucosa tends to be very mobile in relation to
the fixed underlying muscularis propria, full-thickness esophageal perforations
using the Duette multiband device are rare. In the case of malignancy, the
surgeon can accurately assess the T-stage of an early carcinoma using EMR,
which will help plan the extent of esophageal resection and lymphadenectomy
for any given patient. For example, if a carcinoma is confined to the mucosa,
the prevalence of lymph node metastases is less than 10%, allowing minimally
invasive and vagal sparing approaches to esophagectomy, which are associated
with fewer complications and side effects than conventional approaches to this
8
www.cookmedical.com
The Channel
procedure. On the other hand, if the carcinoma
extends into the submucosa, the prevalence
of lymph node disease rises dramatically to
as high as 50%, mandating a more extensive
lymphadenectomy and resection.
Therapeutic Implications
The role of EMR in the therapeutic arena is
evolving, and presently must be considered
to be in its infancy. Therapeutic EMR for
patients with Barrett’s esophagus involves
two distinct clinical scenarios: EMR as a
definitive surgical procedure for a patient
with an early Barrett’s cancer, and EMR as a
tool to actually resect the columnar mucosa
in the absence of a diagnosed cancer. The
concept of EMR as a tool to perform definitive
resection of an early esophageal cancer
was spearheaded in Japan, where certain
intramucosal squamous cell carcinomas are
now considered to be cured by EMR. Applying
this approach to patients with early Barrett’s
cancers, however, warrants caution, since a
significant problem with Barrett’s esophagus is the multifocality of neoplastic
lesions, as well as the risk for metachronous cancers. This risk increases with the
length of the Barrett’s segment. Certainly, patients with early Barrett’s cancers
who are not considered medically fit for esophagectomy may be treated with
EMR, however, the multifocality of neoplasia and the high rate of metachronous
lesions suggests that esophagectomy still must be considered the best treatment,
especially for patients with long columnar-lined segments. Clearly, further
research needs to be performed to determine if EMR plays a role in the definitive
management of carcinoma arising in Barrett’s esophagus.
Welcome to
a section in
The Channel where we present a
clinical image and ask you to participate.
A
EMR is also currently being used to resect entire columnar lined segments
of mucosa in patients with Barrett’s esophagus. With adequate acid
suppression following such a procedure, the columnar-lined segment
tends to become repopulated with normal squamous mucosa. The advantage of
EMR as used in this capacity over other ablative techniques such as photodynamic
therapy and thermal ablation is that the resected mucosa is pathologically
examined, and if carcinoma is found, it can be appropriately treated. A disadvantage
of EMR, however, is that many times EMR needs to be performed circumferentially,
which may lead to more frequent stricture formation, compared to other, more
superficial ablative modalities such as radiofrequency ablation. Whether or not
this strategy effectively prevents against the development of adenocarcinoma in
Barrett’s esophagus is unclear, and prior to widespread adoption, further research
needs to be performed.
47-year-old female
who is 15 years postcholecystectomy suffers
recurrent attacks of acute Dr John Baillie
pancreatitis. A study is
performed that suggests
a risk factor for her pancreatitis.
What kind of study has been
performed? (Be specific.)
What risk factor for pancreatitis
is identified?
What endoscopic intervention
may be helpful?
To confirm your diagnosis, click on
newsletter button on endoscopy
homepage of www.cookmedical.com
<http://www.cookmedical.com>
In summary, the role of EMR in the management of Barrett’s esophagus continues
to evolve. Clearly, it is a superior diagnostic modality compared to traditional
biopsy as well as endoscopic ultrasonography when dealing with small, visible
lesions in the columnar-lined segment. The role of EMR as a definitive resection
technique for patients with Barrett’s esophagus with or without the presence of
early carcinoma remains to be defined.
We are looking for more submissions
to expand this column and welcome
your participation. If you want to
submit an image with a written case
history and clinical explanation, please
contact Kevin Chmura at kevin.chmura@
cookmedical.com.
www.cookmedical.com
9
European endoscopists: “Evolution is a b
i n
c o n t r o l l e
esopha
Peter D. Siersema, M.D., PhD
I
n talking with European physicians about the Cook Medical Evolution Controlled-Release
Stent system phrases like “an ideal stent system” and “ease of use” consistently arise
in discussions. The stent with its
innovative deployment system has
been favorably used in Milan, Italy
and in Utrecht, The Netherlands.
“I was involved in the development
of the Evolution device for the last
four years,”
says Peter D. Siersema, M.D., PhD, Professor of Gastroenterology
and Director of the Department of Gastroenterology and
Hepatology at University Medical Center, Utrecht, The
Netherlands. The Utrecht University is ranked the sixth best
in Europe.
“Evolution makes it very easy to place a stent,
and the stent is a breakthrough in design”
Alessandro
Repici, M.D.
“It allows full control of stent deployment”
Willis G.
Parsons, M.D.
“Our goal
was to develop
an ideal stent system
– including both the stent and the deploying device. Physicians throughout Europe and
the U.S. spent a great deal of time with the Cook engineers. We met every three months,
examining the progress and making suggestions. Each time we met again our suggestions
were incorporated and the product was improved.”
Also involved in the Evolution development were world-renowned gastroenterologists
Alessandro Repici, M.D., Head of the Digestive Endoscopy Unit, Istituto Clinico Humanitas,
Milan, Italy; Willis G. Parsons, M.D., Medical Director of the Gastroenterology Center,
Northwest Community Hospital, Arlington Heights, Illinois; and Todd H. Baron, M.D.,
Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minn.
Evolutionary design enables more control, less stress
Todd H. Baron, M.D.
10
www.cookmedical.com
“The system is unique because it enables the endoscopist to deliver the stent step-by
step,” says Dr. Repici. “It allows full control of stent deployment. By simply squeezing the
trigger, you can deploy the stent centimeter by centimeter. In addition, the physician can
recapture the stent during deployment, even when the stent is already in a very advanced
stage. Physicians can feel much more comfortable knowing they can restart the procedure,
if needed.”
Professor Siersema elaborates: “My colleagues and I appreciate the ease of use in placing
the stent in the esophagus. It is almost a one-handed procedure for one person. The key is
simplicity – Evolution uses a pistol system to release stents for an exact correct positioning.
Thus, the endoscopist can recapture the stent if he is dissatisfied with the position. This is
extremely helpful to other endoscopists who only place stents a few times a year.”
The Channel
breakthrough
e d
r e l e a s e
ageal stenting”
Improved stent offers multiple benefits
“The stent has a very nice flexible design that fits the anatomy of the esophageal structure,”
notes Dr. Repici. “The stent is composed of Nitonol and is silicone-encased on the exterior,
which prevents ingrowth, as well as on the interior, which creates a smoother inner surface
and decreases food bolus impaction. The uncovered proximal and distal flanges anchor
the stent, and this lessens the risk of migration. We know that in the past, 10 to 15 percent
of stents could migrate. We have not experienced that to date with the Evolution.”
Professor Siersema adds: “The stent is very cleverly designed. We have performed 25
procedures in Europe to date, with no evidence of migration in any cases thus far. In
addition, of the cases performed, we have no reports of ingrowth. Also, there has been
low risk for bleeding or other complications.”
Patients benefit from the improved stent
“For the patient, this means a reduced risk of complications
and of recurring dysphasia,” continues Professor
Siersema. “With one stent placed correctly, there is
a reduced need to return for additional procedures
to repeat stent replacements. And because it is
easier for the endoscopist to place the stent exactly,
there is a maximum patient gain in the quality
of swallowing.
“I recall our second Evolution procedure,” he
continues. “The patient, a terminally ill 78-year-old
male from Utrecht, had esophageal cancer that had
metastasized to his liver. He had always loved sharing meals with his family, but the
esophageal dysphasia prevented him from swallowing. We discussed the Evolution stent
procedure with him and he chose to have the procedure. About a day after the stent
placement he was able to enjoy a full course at dinner with his family.”
Dr. Repici also recalls a serious patient case in which the Evolution stent made a life-changing
difference: “A 52-year-old male from Northern Italy presented with a 15 cm esophageal
stricture. Because of this length, other hospitals would not consider an esophageal stent.
At the Istituto Clinico Humanitas, however, our endoscopy group was able to place two
overlapping stents using the Evolution device. Soon after, the patient experienced no
limits in eating. Six weeks after the Evolution stent was placed, the patient returned to the
hospital for another condition, an obstruction of bronchus. When we reopened to clear
this problem, we discovered that the Evolution stent continued performing its function.
The lumen was still perfectly opened.”
“Among my colleagues in Utrecht, the consensus is that Evolution makes it very easy to
place a stent, and the stent is a breakthrough in design. My colleagues and I are very happy
with the results we are experiencing,” concludes Professor Siersema.
The Evolution
Controlled-Release
Stent At a Glance
Evolution handle features
• The endoscopist has precise
control over stent deployment or
recapturability.
• Each squeeze of the trigger
deploys – or recaptures – a
proportional length of stent.
• A directional button enables the
endoscopist to easily shift from
deployment to recapture mode
and back again.
• A “point of no return” mark alerts
the endoscopist when recapture
is no longer possible.
• A safety wire secures the stent
to the handle, ensuring stent
recapturability.
Evolution stent features
• The stent is constructed
of Nitinol.
• Stent lengths are 8 cm,
10 cm, 12.5 cm and 15 cm.
• It is silicone-encased on
the exterior, which prevents
ingrowth.
• The interior is also encased
in silicone, which creates a
smoother inner surface and
decreases food bolus impaction.
• The uncovered proximal
and distal flanges anchor the
stent, to help lessen the risk
of migration.
• A “lasso” loop on the proximal
end provides repositioning the
stent, if necessary, immediately
after placement.
• Four radiopaque markers at
each end provide visualization for
accurate placement.
www.cookmedical.com
11
European and U.S. Gastroenterologists Discuss
“The Evolution of Metal Stenting”
at May 19 San Diego Symposium
O
n Monday, May 19, gastroenterologists worldwide gathered in
San Diego to hear a panel of key opinion leaders discuss the
“Evolution of Metal Stenting.” The discussion, sponsored by Cook Medical,
included these topics:
• Hot topics surrounding metal stents (Eso/Duo/Col),
what the market has available and what the market needs.
Willis G. Parsons, M.D.,
Alessandro Repici, M.D.,
Todd H. Baron, M.D. and
Peter D. Siersema, M.D., PhD
• Development of the first experiences with
Esophageal Evolution.
• Development of the Duo/Col Evolution devices.
First experiences, and the future of metal stenting.
Like the audience, the panelists were world-renowned gastroenterologists.
“The discussion demonstrated that after two years of work, endoscopists and
Cook Medical have developed a product that meets the needs of both physicians
and patients,” says Alessandro Repici, M.D., Head of the Digestive Endoscopy Unit,
Istituto Clinico Humanitas, Milan, Italy. “Attendees learned about Evolution, a
new system, and a new stent that show true advancements in alleviating
esophageal dysphasia.”
“This symposium demonstrated the state-of-the-art system and stent that has been
developed,” adds Peter D. Siersema, M.D., PhD, Professor of Gastroenterology and
Director of the Department of Gastroenterology and Hepatology at the University
Medical Center, Utrecht, The Netherlands. Dr. Siersema, who also assisted in the
development of the Evolution system and stent, calls the device a “milestone in
the field.”
The panel discussion was moderated by Willis G. Parsons, M.D., Medical
Director of the Gastroenterology Center, Northwest Community Hospital,
Arlington Heights, Illinois. Dr. Parsons is nationally recognized for his
work in advanced endoscopic procedures and the management of
pancreatic disease.
Also participating in the discussion was Todd H. Baron, M.D., Professor of Medicine
at the Mayo Clinic College of Medicine in Rochester, Minn. Dr. Baron is nationally
and internationally recognized for his skills in advanced therapeutic endoscopy.
12
www.cookmedical.com
The Channel
EchoTip® Ultra with HDFNA™
With Ultrasonography, Seeing Isn’t Just Believing.
it’s everything.
ultrasound Visibility Comparison
study Description
Ultrasound Visibility Comparison of EchoTip Ultra with
HDFNA and Competitor Needle Aspirators
Cook
Medical
High Definiton
Dimpling
Pattern
Purpose
The purpose of this test was to evaluate the change in
ultrasound visibility of EchoTip Ultra with HDFNA needle
to competitor 1 needle and competitor 2 needle
aspirators when the number of dimples and area of
needle covered by dimples was varied.
Methods
Ultrasound images of each needle evaluated in this
study were provided by Cook Endoscopy. All images
were obtained with the same image settings under
controlled environmental conditions at Johns Hopkins
Hospital by a qualified physician familiar with the use of
the devices and equipment (Sergey Kantsevoy, MD). The
grayscale contrast (average grayscale value in the region
of interest (needle) minus average grayscale value in
the background adjacent to the region of interest) was
measured for each device using Image-Pro PLUS Image
Analysis Software (Media Cybernetics, Silver Spring,
MD). This calculation was selected based on standard
methods for measuring radiopacity of medical devices.
Competitor 1
Low Density
Dimpling
Pattern
The results show that the 22 gauge
echoTip ultra needles with HDFNA will
provide up to 3 times greater contrast
during ultrasound procedures than
competitive needles.
Results
Testing and analysis were performed as outlined
above. Following the measurement of the grayscale
contrast values, t-tests were performed to compare the
Cook Endoscopy EchoTip Ultra with HDFNA needle to
competitor 1 needle and to competitor 2 needle. These
tests showed that the EchoTip Ultra with HDFNA needle
is brighter when viewed under ultrasound (higher
contrast) than both competitor 1 needle (32%) and
competitor 2 needle (182%).
Competitor 2
“Treated Tip”
Full study is on file at Cook Endoscopy, Winston-Salem, NC
www.cookmedical.com
13
A new center for
EUS teaching in France:
Prof. Marc Barthet
Department of Gastroenterology and
Hepatology
Hôpital Nord, Chemin des Bourrely
13915 MARSEILLE Cedex 20 FRANCE
Phone : 33-4-91-96 87 36
Fax : 33-4-91-96 13 11
E mail : marc.barthet@ap-hm.fr
A
lthough EUS appears to be a useful tool with a sufficient scientific background,
it is reputed to be an operator-dependent procedure with a long learning
curve. The value of EUS is directly proportional to the training, skill and experience
of the endosonographer. The lowest annual number of examinations requested
per year might be around 200-250 procedures. The guidelines of the American
Society for Gastrointestinal Endoscopy (ASGE) recommended a minimum of 125
procedures supervised to achieve competence in the diagnosis of mucosal or
submucosal abnormalities. For achieving competence in all the fields of EUS, they
recommended a minimum of 150 supervised cases, 75 of them being devoted
to pancreaticobiliary diseases and 50 to FNA. Thus, the actual offers for EUS
training seems to be insufficient for providing an adequate competence. Many
studies have yet confirmed the importance of the learning curve to improve the
EUS accuracy.
How to learn EUS in France?
EUS training using live pigs.
In France, EUS diploma has been
instituted since 1993. The location of
this course was in Paris with theoretical
course during four weeks and 20 oneday sessions for practicing with an
EUS expert. Evaluation of this EUS
course was performed in 2000. Over
the years 1995-1999, 57 questioners
were answered among 147. Two thirds
of the trainees had done EUS before
the diploma. The trainees enjoyed
theoretical courses, video session and
clinical practice but they asked for
simulator training, and video library. At least 91% would recommend the diploma.
After the diploma delivery, 22% of the trainees had no EUS activity, 23% performed
EUS between 5 and 10/month and 55% in more than 10/month.
A new course for learning EUS has been created in Marseille since 2004. This course
is devoted to certified gastroenterologists at least two years after GE certification
with EUS equipment available speaking or understanding French . Special care was
given for the teaching of EUS relationships with anatomy, oncology, pathology
and radiological features of GI diseases. Teachers were asked to include a lot
of pictures and video during their presentation and CD-ROM including all the
presentations were delivered to all the trainees at the end of the course. The
teaching organization included 3 weeks of theoretical courses and one week for
practical learning with simulator (Symbionix), live EUS sessions and one day of
interventional EUS on live pigs with Fuji, Pentax and Olympus echoendoscopes.
The session with live pigs allowed the trainees to practice FNA, celiac neurolysis,
insertion of guide wire in a cyst through the gastric wall. During the last three years
of the new French EUS Diploma, 77 gastroenterologists received credentials for
EUS practice in Marseille.
14
www.cookmedical.com
The Channel
impact of the live swine model
Which model for learning EUS ?
If EUS learning is frequently self-teaching, there is a real need among
gastroenterologists for increasing EUS competence throughout the credentialing
process. Improving cognitive EUS learning and technique required theoretical
teaching and practical teaching with observation during live demonstration and
echoendoscope hands-on in humans with an expert supervision or with different
simulator models.
It seems to be widely accepted that simulator models are useful to increase or
accelerate the EUS learning process (10-12,16,17). However the superiority of one
simulator model versus another one has not been established. The comparison of
different tools (EUS-FNA box, EUS mentor, EUS RK model, live pig) was assessed
by EUS experts (10). Scores for realism were the highest in the live pig model
with respect to anatomy of pancreatic body and celiac axis, visualization, scope
manipulation, needle manipulation but not for anatomy of mediastinum where the
EUS mentor scored highest. Scores for teaching utility in EUS FNA were highest in
the live pig model but, in teaching EUS alone, the EUS mentor scored slightly higher
than the live pig model. Therefore, the swine model seems to be recommended
by the experts and also by the EUS fellows but this educational tool is difficult to
diffuse widely because of its cost, ethical issues and the need for special rooms
and authorization for these animal laboratory investigations.
In our teaching center (CERC), the live pig model was chosen for EUS credentialing
because it appears to be similar in many respects to the human anatomy, especially
for the pancreas, portal and mesenteric vessels, celiac axis, left kidney and
spleen. In addition, for trainees, it often appears more exciting and stimulating
than virtual model. EUS procedures were located in a new faculty laboratory
dedicated to experimental surgery and endoscopy (CERC). Ethical authorization
and authorization to experiment in live animal for the laboratory unit and for the
EUS expert were all obtained before starting EUS procedures
We have evaluated the impact of the swine model on EUS learning in our teaching
center. Between the pre- and post-test, EUS fellows significantly improved
their competence for the visualization of anatomical structures, i.e. vena cava,
mesenteric/splenic vein, celiac axis, pancreas and bile duct. Each trainee underwent
a total of 22 evaluations during the session day. At the end of the day-session,
trainees were mostly able to recognize and follow these anatomical structures with
echoendoscopes. Interventional EUS learning was also assessed with FNA Cook
needles. A significant decrease in procedural duration and a significant increase in
FNA precision were demonstrated for the puncture of a hilar liver lymph node. In
the live pig, this lymph node is currently found at the liver hilum and easily visible
with the probe through the upper part of the stomach. Consistency and hardness
of this lymph node and difficulty in placement of the probe and the needle are
similar to those seen in the human. Celiac neurolysis was performed after lymph
node FNA. The duration of the procedure was significantly reduced between the
pre-test and the post-test.
Celiac neurolysis in live pig model with
Cook FNA needle
FNA of a liver lymph node with Cook
FNA needle
www.cookmedical.com
15
A
Day of Continuing Education
in Queens, New York
O
n March 1st, fifty nurses from all over the New York area traveled to the
Courtyard Marriot in Queens, for a day of continuing education and hands-on
ERCP interaction. Nurses received continuing education units (CEU) for “Endoscopic
Polypectomy,”“Malignant Biliary Disease,”“Biliary Stone Management,” and “Primary
Sclerosing Cholangitis.”The CEUs were delivered by nurses who had received their
certification through HealthStream®. The speakers were Sally Teich from Winthrop
University, Zen Orfanel from Lenox Hill Hospital, and Carol Ann Hutchinson from
New York Hospital Queens.
As an added bonus, there was a two-hour, hands-on session for ERCP using the
Fusion Advanced ERCP product line. An experienced nurse from Lenox Hill Hospital
championed each of the six groups. The comprehensive training session covered
ERCP techniques such as cannulation with the Fusion OMNItome, performing
stone extraction with the Fusion Quattro Extraction Balloon and Fusion
Lithotripsy Basket, as well as multiple stenting with the Fusion Oasis.
During the session, nurses had the opportunity to manipulate
the ERCP devices and ask questions related to the use of the
products or ERCP in general.
At the end of the day, all agreed that the event was a
success. Each nurse left with a total of four CEUs which
were provided at no charge by Cook Medical’s Endoscopy
division. A special thanks goes to the participating nurses
who delivered the continuing education content and
helped with the hands-on session.
Clarification: In Issue 1, 2008 of The Channel, in the article, “Improvement in multi-stenting of biliary anastomotic strictures after
liver transplantation using Fusion System,” we neglected to mention the facility with which the authors – Dr. Paolo Cantù, MD, and
Prof. Roberto Penagini, MD – are affiliated and its location. That facility is: Fondazione IRCCS Ospedale Maggiore Policlinico, located at Mangiagalli
e Regina Elena in Milan, Italy. We regret the omission and any inconvenience it may have caused.
16
www.cookmedical.com
The Channel
Jean
Brihay
A towering figure
in the world of endoscopy
C
ook Medical Endoscopy division’s first International Sales Representative, Jean
Brihay, retired earlier this year after 25 years of dedicated and inspired service.
With his impeccable professionalism and ample personal charm, Brihay blazed a
trail that made Cook Medical a major presence in the international marketplace.
In 1983, shortly after Bill Cook and Don Wilson co-founded Cook’s Endoscopy
division, the company -- called Wilson-Cook Medical at that time -- had only
produced a few products in the burgeoning field of therapeutic endoscopy. But the
two men had a long-range vision for the future of the company and an important
part of that vision was to establish a strong, vibrant and permanent international
presence. They knew they needed a special person to implement that vision – a
person who possessed exceptional drive and intelligence and charisma. The person
they chose was Jean Brihay.
Brihay wasted no time in establishing dealers to stock and distribute Cook products
in the relatively new specialty of minimally invasive gastroenterology. During his
travels, he also identified clinical and research experts and encouraged them to
not only sample the company’s products but to suggest progressive ideas for new
devices. The relationships he formed with these experts reflected the company’s
philosophy that it maintains to this day: collaborating with clinicians to create
solutions that enhance patient care.
Prof. Nib Soehendra remembers the first time he met Brihay: “I said to Don [Wilson]
that he has found the best man for his European business. Brihay’s contribution to
Cook Europe is tremendous. We clinicians, as the partners of Cook, have benefited
much by our association with Jean.”
Brihay traveled extensively, meeting with and uniting physicians from Europe,
Eastern Europe, and the Middle East. “In the beginning,” says Prof. Jacques Devière,
“Jean would drive throughout Europe in a white car in which he had the WilsonCook exhibition booth always ready to be installed at another meeting. At that time,
Wilson-Cook France and Wilson-Cook Europe consisted of Jean Brihay only.”
For two and a half decades, Brihay worked and collaborated with a litany
of clinicians that reads like a Who’s Who of international thought leaders
in gastroenterology. It would be impossible to list them all, but they
include such notables as: Prof. Nib Soehendra, Prof. Jacques Devière, Prof.
Claude Liguory, Dr. Christopher Williams, Prof. Jean Escourrou, Prof. Michel
Cremer, Prof. Horst Neuhaus, Prof. Thierry Ponchon, Prof. Guido Costamagna,
Years
of dedicated and
inspired service
Jean Brihay
Continued on page 18
www.cookmedical.com
17
Marsha Dryer
Remembered
at
Recognition Dinner
At the SGNA
M eeting in Salt
Lake City, Norah
Connelly, Clinical
Manager, Advocate
Lutheran General
Hospital, Park
Ridge, IL, delivered
a moving tribute
to the late Marsha
Dreyer during the
American Board
of Certification for
Gastroenterology
Nurses (ABCGN) Recognition Dinner.
Dreyer, who worked for more than
three decades alongside some of the
world’s leading gastroenterologists,
a c c o m p l i s h e d m a ny t h i n g s. O n e
of her greatest accomplishments,
Connelly said, was her suppor t of
endoscopy nurses:
“Marsha’s career turned to supporting
nursing education programs both in the
United States and around the world. A big
part of this support was the promotion
and recognition of certification of
gastroenterology nurses and associates.
Marsha was instrumental in promoting
certification by procuring scholarships
for participants to take the certification
exam. At that time there was very little
funding available. In 1989 the first Gala
Recognition dinner was held with Marsha
working behind the scene. This annual
event continues to be sponsored each year
solely by Cook Medical, and it continues to
be a major highlight of the SGNA annual
meeting. When Marsha attended this event
she would say that recognizing GI certified
professionals for their commitment to
patient care and their profession was
important. If Marsha was here she would
applaud you.”
18
www.cookmedical.com
Jean Brihay
Continued from page 17
Prof. Marc Giovannini, Dr. Michel Baize, Prof. Jose Sahel, Prof. Kayse Huibregtse,
Professor Jean Boyer, Prof. Fritz Hagenmüller, Prof. José Armengol-Miro, and Prof.
Ibrahim Mostafa.
Typical of Brihay, these working relationships blossomed into strong, lifelong
friendships. “Apart from his official duties,” says Prof. Soehendra, “Jean treated us
as friends. Other medical disciplines are jealous of us when they see us gathering
together like a real family. In this multinational family, Jean is one of the fathers. I
myself have enjoyed very much all the time in this my second family.”
This “family” often gathered at Brihay’s farmhouse in the French countryside. Prof.
Liguory recalls: “Jean would invite our Belgian and French colleagues to the house,
where we would talk about endoscopy around a table that always included good
food, good wine and good cheer. Jean hosted many doctors during the summer
who would stay from several days to two weeks.”
Prof. Giovannini considers Brihay a “second father.” “He was always protective,
wisely advising me and benevolent. He welcomed me often to his farm in France
where I will long remember the meals he prepared for us. Jean will always have
an important position in my memory and in my heart.”
In addition to the experienced researchers and practitioners who became
his colleagues and friends, Brihay encountered many fledgling clinicians who
needed and wanted further training in the field of therapeutic endoscopy. Brihay
saw this as an opportunity to further Cook’s overall commitment to education.
He began recruiting established clinicians who had a genuine desire to teach and
put them together with clinicians who were eager to learn from the experts. The
classes – designed to go beyond books and manuals – evolved into vigorous,
hands-on sessions.
It was through these educational sessions that Brihay achieved one of his greatest
legacies – the development of “the endoscopic workshop.” These workshops
brought the “students” right into the procedure room, observing and working
alongside the expert physicians, asking them questions and working directly with
patients. “Jean created a true international network of therapeutic endoscopists,”
says Prof. Devière, “which dramatically influenced the international collaboration
in Europe.”
Brihay also leaves another legacy: his sense of humor. Where Brihay went, laughter
often followed. “As well as his unfailing kindness and cheerfulness,” says Dr.
Williams, “I suppose that one invariable attribute is his ability to produce some
humorous story, and then to laugh at the joke himself with a noise and gusto of
volcanic proportions. No gathering at which Jean is present can avoid these loud
explosions of hilarity.”
A quarter-century career – especially one as full and varied as Jean Brihay’s –
is difficult to sum up in a single sentence, but Prof. Devière comes very close:
“This gentleman is a towering figure in the world of endoscopy; a man that two
generations of endoscopists, at least, will always remember for his education,
generosity, humanism and professionalism.”
© 2008 Cook Medical
The Channel
More Control,
Less Stress
The more control you have in a stent placement procedure, the less
stressful that procedure can be. That’s why we created Evolution, the
only stent delivery system with controlled release and recapturability.
Now, with unprecedented precision, you can deploy or recapture the
stent. That means, if necessary, you get a second chance to perform a
first-rate stent placement.
To learn more, visit cookmedical.com and click Endoscopy.
AORT IC INT ERV ENT I O N
CA R D I O LO GY
C R I TI CA L CA R E
E N DO S CO PY
P E R I P H E R A L I N T E RV E N T I O N
S U R G E RY
U R O LO GY
WO M E N ’ S HE ALT H
www.cookmedical.com
15
upcoming events
MAYO 08 EUS Course
Rochester, MN
July 31 Aug. 2
Gasteroenterology & Endoscopy Argentinean Congress
Buenos Aires,
Argentina
Aug. 1-4
CSGNA (Canadian Soc. of Gastroenterological Nurses)
Vancouver
Sept. 11-13
Asian Pacific Digestive Week
New Dehli
Sept. 13-16
Rochester, MN
Sept. 25-26
Boston Live Endoscopy
Boston, MA
Sept. 26-28
Japanese DDW
Tokyo, Japan
Oct. 1-4
ACG (American College of Gastroenterology)
Orlando, FL
Oct. 3-8
UEGW
Vienna, Austria
Oct. 18-22
21st International Course on Therapeutic Endocopy
Toronto, Canada
Oct. 22-25
Australian Gastro Week
Brisbane,
Australia
Oct. 22-26
AASLD (Liver Meeting)
San Francisco, CA
Oct. 31 Nov 4
Nov 29 Dec. 1
MAYO ERCP A-Z
Cook Endoscopy has long understood that optimal
patient care is your focus, and it continues to be
our focus as well. That’s why for more than twenty
years we have assisted healthcare professionals
in learning the latest in endoscopic GI technology
and related disease information.
That tradition continues as Cook Endoscopy, in
partnership with HealthStream (an accredited
provider of continuing nursing education), offers
three educational activities:
Malignant Biliary Disease
Biliary Stone Management
10th International Workshop on Therapeutic Endocopy
Milano, Italy
23rd International Workshop on Therapeutic Endocopy
Hong Kong,
China
Dec. 9-12
NYSGE
New York, NY
Dec. 17-20
An official publication of Cook Endoscopy.
4900 Bethania Station Rd., Winston-Salem, NC 27105
P: 336-744-0157 F: 336-744-5785
If you would like to submit material for The Channel, please email us at
thechannel@cookmedical.com. We welcome your comments and suggestions.
Primary Sclerosing Cholangitis
These activities are presented without charge
by your Cook Endoscopy Representative, and
each offers one contact hour. Educational
activity descriptions, objectives, and the related
accreditation information can be found at http://
www.cookendoscopy.com/education/pages/
edprograms.html
Contact your Cook representative for more
information or to arrange a presentation
opportunity.
A continuing nursing education activity sponsored by
HealthStream. Grant funds provided by Cook Medical.
20
www.cookmedical.com
18804/0508