Gregg
M. Gaylord,
MD
Vascular Interventional the Development ofNew Marketing, and the Auk’ A CAUTION
Consider Becoming
TO
EVERYBODY
the Auk; extinct because
to fly, Consider
“laser”
he forgot
how
become
in crossing that “some
Because he forgot how to walk and learned how to fly before he thinked.
I
Belli and colleagues present a randomized prospective comparison of conventional guide wires versus laser thermal technology to achieve primary recanalization of total peripheral artery occlusions this
N
(2).
of Radiology,
issue
In
their
series,
total occlusions artery (n = 68)
81 patients
of the
with
84
femoropopliteal
plasty
with
iliac
a hybrid
artery
probe.
No
laser
with
the opposite
probe
succeeded
nalization crossed while
of six of nine
cross
resistant
to laser
three
six
but not suprising lesions
crossed
Index terms:
Arteries, laser #{149} Arteries, transluminal #{149} Editorials #{149} Lasers
9*1282 9*1282
not
methods, were used of six lesions
to
therapy.
It is interesting of the
The reca-
occlusions
with conventional conventional means
successfully
five
method.
1
From
1991;
the
that
with
angioplasty,
of Diagnostic
Radio!-
ogy,
Methodist Hospital of Indiana, 1701 N SenIndianapolis, IN 46202. Received July 1, 1991; accepted July 2. Address reprint re-
ate Blvd, quests
to the author.
2 9* indicates volvement.
C RSNA,
See also this issue.
generalized
vein
and
artery
in-
1991
the article
by Be!li
et al (pp
which true
state for ad-
prolumen.”
that
was
the use of laser
energy
of little
or no value in crossing obstructing lesions resistant to conventional means of
recanalization. data
Further
reveals
between
“no
analysis
significant
the two
of their for success-
fully crossing femoropoliteal occlusions.” All studies were performed
experienced catheter-guide
and
laser
with
What previous
distinguishes evaluations
techniques
to traverse
ventional
attempts
making
probe.
For most
with
wire
attempts
with
vascular
57-60)
in
fair
to say
that
in 1989
deal of uncertainty laser coupled with
there
was
over the future an anxiety that
a great
of radi-
ologists might lose a “turf battle” to vascular surgeons and cardiologists over the domain of peripheral vascular procedures. How have attitudes changed since then?
I recently completely leagues,
conducted
unscientific all engaged
interventional
an informal, poll of 12 colin cardiovascular
radiology
as a full-
time or nearly full-time occupation. I asked each to play a word-association game, giving me the first answer “off the top of their heads” when I mentioned a word. My word was laser. To this, nine of the 12 responded with an identical single-word answer: failure.
The other three money,” “waste
answered of time,”
“waste of and “it has
possible great potential, though it currently has not succeeded.” I then asked each to rate laser and the Terumo
by the au-
occlusions
catheter-guide
before
for
translu-
this study from of laser technology
are the aggressive thors
by
both contech-
wire
thermal
article by Levy et al questioned the value of laser-assisted PTA in the cornmunity hospital setting (8). It might be
and
difference
techniques
con-
methods a laser
interventional
radiologists
practicing
in institutions
where laser the threshold
technology has yet to cross of the angiography-suite
doors, Beffi et al provide one more reason to avoid the purchase of a costly system that, to date, has shown no significant clinical utility (3-5). One can only wonder how much more damaging to laser the data would be if the authors had included popliteal punctures in their attempts to cross lesions resistant to conventional methods.
Previous editorials in 1989 by McLean et a! (6) and Strandness et al (7) warned of the dangers in investing in expen-
angioplasty,
181:15-16
Department
the authors was needed
British proit is clear
Glidewire (Meditech/Boston Scientific, Watertown, Mass) on a scale of 1-10 with 10 being the highest positive score. The answers averaged 2 for laser and 9 for the Glidewire. I suspect if I were to take a nationwide poll of cardiovascular interventional radiologists, the results would be similar (readers are invited to send
their
responses).
Are we now ably
not
to condemn
lasers?
Prob-
as it was
premature
to
(9). Just
promote laser as a major advance in the treatment of peripheral vascular or coronary atherosclerotic disease, it is not yet time to condemn the potential of laser energy as a tool for ablation of atherosclerotic disease. Many questions
McLean imagine
et al state that “it is difficult to that a significant number of
to be answered about the develof atherosclerosis, the effect of PTA on the arterial wall, the distribution of plaque in a diseased vessel, the mech-
stenoses application
can
anism
sive, Radiology
laser probe. For the laser energy was used
performance of percutaneous minal angioplasty (PTA).
iliac
in primary
treated
Even if one were to ignore pensity for understatement,
niques
lesions were successfully recanalized with laser techniques (n = 7), while conventional means were used to successfully traverse six of nine iliac occlusions. When the initial method failed in femoropopliteal lesions (nine of 34 in the conventional group versus six of 34 in the laser group), lesions were then
treated
conventional
actually
a lesion, pressure
radiologists ventional
(n = 16) were randomized to primary recanalization attempts with conventional guidewire techniques or laser thermal angioand
were
vancement of the probe, ceeded to recanalize the
(1)
NASH]
after
failed
with a nonactivated one case in which
extinct
[OGDEN
techniques
attempts
and could only walk. man, who may well
Radiologists, Technologies,
unproved
technology.
In fact,
be crossed only with the of laser energy.” Strandness “the . . . use of lasers as
et al chastise public relations
and
marketing
tools,
remain opment
of stimulation
of neointimal hyof other technologies (ie, intravascular ultrasound), in the treatment of atherosclerosis.
perplasia, or
as means for untrained specialists to practice on patients,” thus subjecting patients “not only to unproved technology but to procedures performed by those with little expertise or appropriate previous experience.” Earlier in 1989, an
Work
and
by Johnson
the utility
(10), Waller
(11), and
others has stimulated interest in the biochemistry of atherosclerosis. With these as well as many other areas of investigation remaining, it would be foolhardy to ignore a technology that may yet prove 15
to have a significant role in the treatment of our patients. Despite best intentions, it may prove impossible to develop an efficient and effective system for testing new interventional technologies. If cardiovascular and interventional radiologists are to maintain the goal of serving patients to the best of their abilities, however, we must strive to maintain credibility and
newer products or modifications of currently accepted products, provides jobs, and stimulates further research. Marketing also serves to inform people of “what is out there.” Conversely, tightly controlled centralized economies, most of which forbid mass marketing of products by private companies or mdividuals, have trouble funding the mas-
integrity.
logically
A growing
trend
among
the
public, insurance companies, businesses, government, and the press is to question the motivation and judgment of physicians. The June 30, 1991, national edition of the New York Times contained a headline story with the subtitle “The Battle of the Heart Drugs” (12).
The
front-page
article
and
full-
page spread on page nomic, moral, ethical,
10 address the ecoand scientific is-
sues
controversy
surrounding
the
of the
use of recombinant tissue plasminogen activator (rTPA) versus streptokinase (SK) for the treatment of acute myocardial infarction. The article goes on to state that at $2,200 per rTPA treatment versus $76 to $300 per 5K treatment, it took a powerful display of drug company marketing . . . and some early data showing that [rTPA] was better ... to stir up such a frenzy among cardiolo“.
gists
.
.
that
[rTPAJ
some
its astounding
unlike tional
were
afraid
for fear of getting that
price.”
faced
radiologists
not
to use
sued,
despite
This
issue
by vascular with
regard
is not
intervento laser
therapy and administration of low-osmolar contrast media. Marketing techniques are powerful tools, as evidenced by the tremendous influence of television advertising. At best, marketing helps derive large amounts of capital from private sources. This allows further development of
16
#{149} Radiology
sive
projects
term links
required
oriented
thinking
to sustain
societies.
techno-
When
predominates
short-
and
References 1.
2.
randomized 3.
marketing
5.
The link between the virtues of marketing and their value to our patients is formed in the mind of the individual practicing physician. It is ultimately our responsibility to recognize the difference between virtue and hype. As the
editorials
of the
past
have
shown, radiologists are capable sound judgment when it comes development of new technologies. eschewing economically driven ing ploys, however, and instead moting experience and knowledge, cular interventional radiologists outlast the fads and gimmickry inevitably
develop
in the
course is the time
careers. Perhaps now a moment and reflect position
toward
the
of to the By marketprovascan that will
proudly development
of
laser technology taken by some of the leaders in the field of vascular interventional radiology. It is hoped that good judgment inthefuture.
will
continue
#{149}
to serve
us well
In: The
versus
with a hybrid
angioplasty-results
laser
probe
of a 181:57-
1991;
60. Spies JB, LeQuire MH, Brantley SD, WilliamsJE, Beckett WC, MiIISJL. Com-
parison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropoplitea! atherosclerotic disease: initial results of a prospective randomized trial. Work in progress. JVIR 1990; 1:39-42. Douek PC, Leon MB, Geschwind H, et a!. Occlusive peripheral vascular disease: a multicenter trial of fluorescence-guided, pulsed dye laser-assisted balloon angiop!asty. Radiology 1991; 180:127-133. LammerJ, Pilger E, Karnel F, et a!. Laser
1991;
results of a prospective, multiat 3-year follow-up. Radiology
178:335-337.
McLean
GK, Burke
Comment 1989;
DR. Marineffi
on the clinical
of an emerging
DL.
appropriateness
technology.
Radiology
172:941-942.
7.
Strandness
8.
Ring EJ. Indiscriminate use of laser angioplasty. Radiology 1989; 172:945-946. Levy JM, Hessel SJ, Hors!ey WW, Cook GC, Dickay JE. Value of laser-assisted angioplasty in the community hospital. Radiology
9.
10.
1989;
DE Jr. Barnes
RW, Katzen
B,
170:1017-1018.
Bonn J. Clinical utility of laser recanalization in occluded peripheral arteries. Radiology 1991; 178:323-325. Johnson DE. Directional peripheral
atherectomy: histopathologic new interventional technique.
of their
to take on the
guide-wire
trial. Radiology
angioplasty: center study 6.
to everybody.
recanakzation
in percutaneous
ethical
salespeople.
A caution
conventional
thermal
4.
and
0.
pocket book of Ogden Nash. New York: Washington Square Press, 1978; 36. Belli AM, Cumber!and DC, Procter AE, Welsh CL. Total peripheral artery occ!usions:
are severed in the development of medical technology and when promotion to raise capital becomes an end in itself, patients suffer the ultimate burden of unnecessary procedures, unnecessary costs, and possible injury. The point at which the ethical link is formed, however, is not in the minds of managers
Nash
aspects of a JVIR 1990;
1:29-33.
11.
12.
Waller BF. Pathology of translumina! balloon angioplasty used in the treatment of coronary heart disease. Hum Pathol 1987; 18:476-484. Pollock A. Both heart drugs are effective; doctors prescribe the costly one. New York Times. 1991 June 30:1.
October
1991
M. Gaylord,
MD
Vascular Interventional the Development ofNew Marketing, and the Auk’ A CAUTION
Consider Becoming
TO
EVERYBODY
the Auk; extinct because
to fly, Consider
“laser”
he forgot
how
become
in crossing that “some
Because he forgot how to walk and learned how to fly before he thinked.
I
Belli and colleagues present a randomized prospective comparison of conventional guide wires versus laser thermal technology to achieve primary recanalization of total peripheral artery occlusions this
N
(2).
of Radiology,
issue
In
their
series,
total occlusions artery (n = 68)
81 patients
of the
with
84
femoropopliteal
plasty
with
iliac
a hybrid
artery
probe.
No
laser
with
the opposite
probe
succeeded
nalization crossed while
of six of nine
cross
resistant
to laser
three
six
but not suprising lesions
crossed
Index terms:
Arteries, laser #{149} Arteries, transluminal #{149} Editorials #{149} Lasers
9*1282 9*1282
not
methods, were used of six lesions
to
therapy.
It is interesting of the
The reca-
occlusions
with conventional conventional means
successfully
five
method.
1
From
1991;
the
that
with
angioplasty,
of Diagnostic
Radio!-
ogy,
Methodist Hospital of Indiana, 1701 N SenIndianapolis, IN 46202. Received July 1, 1991; accepted July 2. Address reprint re-
ate Blvd, quests
to the author.
2 9* indicates volvement.
C RSNA,
See also this issue.
generalized
vein
and
artery
in-
1991
the article
by Be!li
et al (pp
which true
state for ad-
prolumen.”
that
was
the use of laser
energy
of little
or no value in crossing obstructing lesions resistant to conventional means of
recanalization. data
Further
reveals
between
“no
analysis
significant
the two
of their for success-
fully crossing femoropoliteal occlusions.” All studies were performed
experienced catheter-guide
and
laser
with
What previous
distinguishes evaluations
techniques
to traverse
ventional
attempts
making
probe.
For most
with
wire
attempts
with
vascular
57-60)
in
fair
to say
that
in 1989
deal of uncertainty laser coupled with
there
was
over the future an anxiety that
a great
of radi-
ologists might lose a “turf battle” to vascular surgeons and cardiologists over the domain of peripheral vascular procedures. How have attitudes changed since then?
I recently completely leagues,
conducted
unscientific all engaged
interventional
an informal, poll of 12 colin cardiovascular
radiology
as a full-
time or nearly full-time occupation. I asked each to play a word-association game, giving me the first answer “off the top of their heads” when I mentioned a word. My word was laser. To this, nine of the 12 responded with an identical single-word answer: failure.
The other three money,” “waste
answered of time,”
“waste of and “it has
possible great potential, though it currently has not succeeded.” I then asked each to rate laser and the Terumo
by the au-
occlusions
catheter-guide
before
for
translu-
this study from of laser technology
are the aggressive thors
by
both contech-
wire
thermal
article by Levy et al questioned the value of laser-assisted PTA in the cornmunity hospital setting (8). It might be
and
difference
techniques
con-
methods a laser
interventional
radiologists
practicing
in institutions
where laser the threshold
technology has yet to cross of the angiography-suite
doors, Beffi et al provide one more reason to avoid the purchase of a costly system that, to date, has shown no significant clinical utility (3-5). One can only wonder how much more damaging to laser the data would be if the authors had included popliteal punctures in their attempts to cross lesions resistant to conventional methods.
Previous editorials in 1989 by McLean et a! (6) and Strandness et al (7) warned of the dangers in investing in expen-
angioplasty,
181:15-16
Department
the authors was needed
British proit is clear
Glidewire (Meditech/Boston Scientific, Watertown, Mass) on a scale of 1-10 with 10 being the highest positive score. The answers averaged 2 for laser and 9 for the Glidewire. I suspect if I were to take a nationwide poll of cardiovascular interventional radiologists, the results would be similar (readers are invited to send
their
responses).
Are we now ably
not
to condemn
lasers?
Prob-
as it was
premature
to
(9). Just
promote laser as a major advance in the treatment of peripheral vascular or coronary atherosclerotic disease, it is not yet time to condemn the potential of laser energy as a tool for ablation of atherosclerotic disease. Many questions
McLean imagine
et al state that “it is difficult to that a significant number of
to be answered about the develof atherosclerosis, the effect of PTA on the arterial wall, the distribution of plaque in a diseased vessel, the mech-
stenoses application
can
anism
sive, Radiology
laser probe. For the laser energy was used
performance of percutaneous minal angioplasty (PTA).
iliac
in primary
treated
Even if one were to ignore pensity for understatement,
niques
lesions were successfully recanalized with laser techniques (n = 7), while conventional means were used to successfully traverse six of nine iliac occlusions. When the initial method failed in femoropopliteal lesions (nine of 34 in the conventional group versus six of 34 in the laser group), lesions were then
treated
conventional
actually
a lesion, pressure
radiologists ventional
(n = 16) were randomized to primary recanalization attempts with conventional guidewire techniques or laser thermal angioand
were
vancement of the probe, ceeded to recanalize the
(1)
NASH]
after
failed
with a nonactivated one case in which
extinct
[OGDEN
techniques
attempts
and could only walk. man, who may well
Radiologists, Technologies,
unproved
technology.
In fact,
be crossed only with the of laser energy.” Strandness “the . . . use of lasers as
et al chastise public relations
and
marketing
tools,
remain opment
of stimulation
of neointimal hyof other technologies (ie, intravascular ultrasound), in the treatment of atherosclerosis.
perplasia, or
as means for untrained specialists to practice on patients,” thus subjecting patients “not only to unproved technology but to procedures performed by those with little expertise or appropriate previous experience.” Earlier in 1989, an
Work
and
by Johnson
the utility
(10), Waller
(11), and
others has stimulated interest in the biochemistry of atherosclerosis. With these as well as many other areas of investigation remaining, it would be foolhardy to ignore a technology that may yet prove 15
to have a significant role in the treatment of our patients. Despite best intentions, it may prove impossible to develop an efficient and effective system for testing new interventional technologies. If cardiovascular and interventional radiologists are to maintain the goal of serving patients to the best of their abilities, however, we must strive to maintain credibility and
newer products or modifications of currently accepted products, provides jobs, and stimulates further research. Marketing also serves to inform people of “what is out there.” Conversely, tightly controlled centralized economies, most of which forbid mass marketing of products by private companies or mdividuals, have trouble funding the mas-
integrity.
logically
A growing
trend
among
the
public, insurance companies, businesses, government, and the press is to question the motivation and judgment of physicians. The June 30, 1991, national edition of the New York Times contained a headline story with the subtitle “The Battle of the Heart Drugs” (12).
The
front-page
article
and
full-
page spread on page nomic, moral, ethical,
10 address the ecoand scientific is-
sues
controversy
surrounding
the
of the
use of recombinant tissue plasminogen activator (rTPA) versus streptokinase (SK) for the treatment of acute myocardial infarction. The article goes on to state that at $2,200 per rTPA treatment versus $76 to $300 per 5K treatment, it took a powerful display of drug company marketing . . . and some early data showing that [rTPA] was better ... to stir up such a frenzy among cardiolo“.
gists
.
.
that
[rTPAJ
some
its astounding
unlike tional
were
afraid
for fear of getting that
price.”
faced
radiologists
not
to use
sued,
despite
This
issue
by vascular with
regard
is not
intervento laser
therapy and administration of low-osmolar contrast media. Marketing techniques are powerful tools, as evidenced by the tremendous influence of television advertising. At best, marketing helps derive large amounts of capital from private sources. This allows further development of
16
#{149} Radiology
sive
projects
term links
required
oriented
thinking
to sustain
societies.
techno-
When
predominates
short-
and
References 1.
2.
randomized 3.
marketing
5.
The link between the virtues of marketing and their value to our patients is formed in the mind of the individual practicing physician. It is ultimately our responsibility to recognize the difference between virtue and hype. As the
editorials
of the
past
have
shown, radiologists are capable sound judgment when it comes development of new technologies. eschewing economically driven ing ploys, however, and instead moting experience and knowledge, cular interventional radiologists outlast the fads and gimmickry inevitably
develop
in the
course is the time
careers. Perhaps now a moment and reflect position
toward
the
of to the By marketprovascan that will
proudly development
of
laser technology taken by some of the leaders in the field of vascular interventional radiology. It is hoped that good judgment inthefuture.
will
continue
#{149}
to serve
us well
In: The
versus
with a hybrid
angioplasty-results
laser
probe
of a 181:57-
1991;
60. Spies JB, LeQuire MH, Brantley SD, WilliamsJE, Beckett WC, MiIISJL. Com-
parison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropoplitea! atherosclerotic disease: initial results of a prospective randomized trial. Work in progress. JVIR 1990; 1:39-42. Douek PC, Leon MB, Geschwind H, et a!. Occlusive peripheral vascular disease: a multicenter trial of fluorescence-guided, pulsed dye laser-assisted balloon angiop!asty. Radiology 1991; 180:127-133. LammerJ, Pilger E, Karnel F, et a!. Laser
1991;
results of a prospective, multiat 3-year follow-up. Radiology
178:335-337.
McLean
GK, Burke
Comment 1989;
DR. Marineffi
on the clinical
of an emerging
DL.
appropriateness
technology.
Radiology
172:941-942.
7.
Strandness
8.
Ring EJ. Indiscriminate use of laser angioplasty. Radiology 1989; 172:945-946. Levy JM, Hessel SJ, Hors!ey WW, Cook GC, Dickay JE. Value of laser-assisted angioplasty in the community hospital. Radiology
9.
10.
1989;
DE Jr. Barnes
RW, Katzen
B,
170:1017-1018.
Bonn J. Clinical utility of laser recanalization in occluded peripheral arteries. Radiology 1991; 178:323-325. Johnson DE. Directional peripheral
atherectomy: histopathologic new interventional technique.
of their
to take on the
guide-wire
trial. Radiology
angioplasty: center study 6.
to everybody.
recanakzation
in percutaneous
ethical
salespeople.
A caution
conventional
thermal
4.
and
0.
pocket book of Ogden Nash. New York: Washington Square Press, 1978; 36. Belli AM, Cumber!and DC, Procter AE, Welsh CL. Total peripheral artery occ!usions:
are severed in the development of medical technology and when promotion to raise capital becomes an end in itself, patients suffer the ultimate burden of unnecessary procedures, unnecessary costs, and possible injury. The point at which the ethical link is formed, however, is not in the minds of managers
Nash
aspects of a JVIR 1990;
1:29-33.
11.
12.
Waller BF. Pathology of translumina! balloon angioplasty used in the treatment of coronary heart disease. Hum Pathol 1987; 18:476-484. Pollock A. Both heart drugs are effective; doctors prescribe the costly one. New York Times. 1991 June 30:1.
October
1991
