The Birth, Early Years, and Future of
`Interventional Radiology
`
`Josef Rösch, MD, Frederick S. Keller, MD, and John A. Kaufman, MD
`
`J Vasc Interv Radiol 2003; 14:841–853
`
`Abbreviations: AGIB ⫽ acute gastrointestinal bleeding, PTA ⫽ percutaneous transluminal angioplasty, SFA ⫽ superficial femoral artery, SIR ⫽ Society of In-
`terventional Radiology, SK ⫽ streptokinase, TIPS ⫽ transjugular intrahepatic portosystemic shunt
`
`THE Society of Interventional Radiol-
`ogy (SIR) celebrates its 30th anniver-
`sary this year. During these 30 years,
`SIR has grown from a closed club with
`fewer than 100 members to an open
`society with 4,000 members. The his-
`tory of the Society and its exciting
`growth is detailed on the SIR web site,
`www.sirweb.org. This issue of JVIR also
`contains commemorative articles of
`some founding members on the for-
`mative years of SIR, its transition to an
`open society, perspectives for its fu-
`ture, and the history of nonvascular
`interventions. However, only a few
`SIR members remember the birth and
`early years of interventional radiol-
`ogy. It is our intention to bring these
`days back to you by recounting how
`interventional radiology was born and
`how it grew, particularly in the area of
`vascular interventions.
`This article is a remembrance, a col-
`lection of the highlights of our memo-
`ries of events that happened 25–40
`years ago, documented by historic pic-
`tures. Fortunately, the human memory
`has the most generous and merciful
`nature; it encrypts in the mind exciting
`and memorable events while repress-
`ing unemotional or disturbing occa-
`sions or at least permitting us to look
`at them differently. Many of the mo-
`
`From the Dotter Interventional Institute, Oregon
`Health and Science University, 3181 SW Sam Jack-
`son Park Road, L342, Portland, Oregon 97239.
`Address correspondence to J.R.; E-mail: roschj@
`ohsu.edu
`
`© SIR, 2003
`
`DOI: 10.1097/01.RVI.0000083840.97061.5b
`
`mentous events associated with the
`birth and early years of interventional
`radiology are still as fresh in our mem-
`ory as if they occurred yesterday. But,
`because the human memory is also
`quite subjective, our memories could
`be somewhat biased as we take you
`back into the exciting early years of
`interventional radiology.
`
`THE BIRTH OF
`INTERVENTIONAL
`RADIOLOGY
`Interventional radiology developed
`from diagnostic angiography and
`from the innovative minds and techni-
`cal
`skills of many angiographers.
`Charles Dotter (Fig 1) (1) conceived
`interventional radiology in the early
`1960s and first officially spoke about it
`on June 19, 1963, at the Czechoslovak
`Radiological Congress
`in Karlovy
`Vary. In his more than 1 hour presen-
`tation, “Cardiac catheterization and
`angiographic techniques of
`the fu-
`ture,” he discussed, among other top-
`ics, catheter biopsy, controlled exit
`catheterization, occlusion catheteriza-
`tion for various purposes, and the ra-
`tionale of catheter endarterectomy (2).
`After his conclusion stating that “[t]he
`angiographic catheter can be more
`than a tool for passive means for diag-
`nostic observation; used with imagina-
`tion, it can become an important sur-
`gical instrument,” Charles received a
`standing ovation from more than 300
`attendees, including many prominent
`European angiographers. For those of
`us in the audience, it was like a bomb
`had been dropped. At that time, all
`
`angiographers had only one thing in
`mind, to deliver an exact diagnosis to
`our referring clinical colleagues, inter-
`nists and surgeons, thereby allowing
`them to select proper treatment. Until
`then, none of us had even thought that
`we might be able to treat patients our-
`selves percutaneously with use of
`catheters and guide wires. Also, none
`of us present at the congress realized
`or even dreamed that Dotter’s words
`would soon become reality.
`Interventional radiology was born
`January 16, 1964, when Dotter percu-
`taneously dilated a tight, localized ste-
`nosis of the superficial femoral artery
`(SFA) in an 82-year-old woman with
`painful
`leg ischemia and gangrene
`who refused leg amputation. After
`successful dilation of the stenosis with
`a guide wire and coaxial Teflon cath-
`eters, the circulation returned to her
`leg (Fig 2) (3). Charles told us that his
`skeptical surgical colleagues kept the
`patient in the hospital under observa-
`tion for several weeks expecting the
`dilated artery to thrombose. Instead,
`her pain ceased, she started walking,
`and three irreversibly gangrenous toes
`spontaneously sloughed. She left the
`hospital on her feet—both of them.
`The dilated artery stayed open until
`her death from pneumonia 2.5 years
`later.
`Encouraged by this success, Dotter
`not only continued to dilate SFA ste-
`noses, but also began treatment of SFA
`occlusions. In his first paper on this
`subject published in the November
`1964 issue of Circulation (3), Dotter—
`with Melvin Judkins, developer of
`transfemoral coronary catheterization
`
`841
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`842 (cid:127) The Birth, Early Years, and Future of Interventional Radiology
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`July 2003
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`JVIR
`
`tions were averted in these patients. In
`the description of the technique, Dot-
`ter
`recommended “passing guide
`wires through the lesions more by the
`application of judgment than of force,
`even when both are often needed for
`subsequent dilation.” Force was in-
`deed often necessary when passing
`the 15-F outer diameter dilation cath-
`eter over the first 9-F catheter. Dotter’s
`experience rapidly grew, and in May
`1966, he reported treatment of 82 le-
`sions in 74 patients, including six iliac
`artery stenoses. This report also men-
`tioned the first use of braided mesh
`reinforced latex balloon dilation cath-
`eters (3A).
`Dotter refined his technique and
`decreased the size of coaxial dilation
`catheters to 8 F and 12 F and improved
`the taper of their tips. In 1968, 4 years
`after his first case, he reported on 217
`dilations of 153 lesions in 127 patients
`(4). Dotter considered himself a “body
`plumber” and, to avoid reference to
`his technique as “reaming out,” he
`drew and published a picture of his
`concept of the basic mechanism of
`transluminal dilation in which nothing
`is removed except for the obstruction.
`Dotter, for a long time, called his tech-
`nique
`“percutaneous
`transfemoral
`catheter dilatation,” but later changed
`it to the presently known “percutane-
`ous transluminal angioplasty” (PTA).
`The term “interventional radiol-
`ogy” was coined by Alexander Margu-
`lis in his editorial in the March 1967
`issue of the American Journal of Roent-
`genology (5). In the mid 1960s, occa-
`sional reports were published on treat-
`ment with radiologic techniques other
`than PTA or on new manipulative di-
`agnostic radiologic procedures. These
`included treatment of rigid shoulders
`by joint distention during arthrogra-
`phy, abscess drainages,
`intrauterine
`transfusion of the fetus under fluoro-
`scopic guidance, removal of plugs
`from a T-tube by fluoroscopically con-
`trolled catheter manipulation, pulmo-
`nary and liver biopsy, catheter place-
`ments for intraarterial chemotherapy,
`and transjugular
`cholangiography.
`Margulis, a gastrointestinal radiologist
`and educator, realized that a new
`trend and new specialty was develop-
`ing in radiology. In his editorial, he
`not only defined interventional radiol-
`ogy, but also set requirements for its
`performance that are still valid today.
`He defined interventional radiology as
`
`Figure 1. Charles Dotter and his trademark (trademark drawing reprinted with permis-
`sion from reference 1).
`
`Figure 2. The first percutaneous transluminal angioplasty, performed January 16, 1964
`(reprinted with permission from reference 3).
`
`technique (Fig 3)—summarized their
`5-month experience with angioplasty.
`They reported treatment of 11 extrem-
`ities in nine patients, including four
`
`with short SFA occlusions and four
`with long SFA occlusions. The treat-
`ment of occlusions was not always
`successful, but four of seven amputa-
`
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`Volume 14 Number 7
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`Rösch et al (cid:127) 843
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`structure led to new indications for
`interventional procedures. Examples
`include our introduction of selective
`arterial
`thrombolysis and fallopian
`tube recanalization. More recent de-
`vices and techniques such as stents,
`stent-grafts, transjugular intrahepatic
`portosystemic shunt (TIPS) creation,
`and direct intrahepatic portal systemic
`shunt creation underwent detailed ex-
`perimental
`testing in animals and
`were introduced for clinical use with
`approval of the institutional review
`board.
`Departments in other institutions
`were developing devices and tech-
`niques in a similar fashion. Interven-
`tional
`treatment
`that
`started with
`opening vascular obstructions
`ex-
`panded to creating therapeutic vascu-
`lar occlusions and shunts and treating
`tumors. Its application also expanded
`from the vascular system to the pul-
`monary, biliary, gastrointestinal, geni-
`tourinary, and central nervous sys-
`tems. There were many pioneers who
`introduced new methods of interven-
`tional
`treatment. We will highlight
`some of them and concentrate mainly
`on interventional treatment related to
`the vascular system, particularly PTA,
`local thrombolysis, stent development,
`treatment of acute gastrointestinal
`bleeding, and TIPS creation.
`
`EARLY HIGHLIGHTS IN
`PERCUTANEOUS
`TRANSLUMINAL
`ANGIOPLASTY
`After a few successful procedures,
`Dotter started an aggressive campaign
`to recruit patients and gain recogni-
`tion for PTA. His
`referrals were
`mainly from general practitioners and
`occasionally from internists. Surgeons
`were not
`interested in nonsurgical
`treatment of atheromatous disease
`and were adamantly opposed to PTA.
`Dotter’s articles in local newspapers
`and his radio and TV interviews were
`effective in attracting patients inter-
`ested in this new procedure. These pa-
`tients were admitted to the hospital on
`the radiology service under Dotter’s
`name and radiology residents or fel-
`lows, with varying degrees of enthu-
`siasm, worked them up and prepared
`for the procedure.
`Patient recruitment was greatly en-
`hanced on a national level with a Life
`magazine article on PTA and Dotter.
`
`Figure 3.
`Melvin Judkins
`with his coro-
`nary catheters.
`
`manipulative procedures controlled
`and followed under fluoroscopic guid-
`ance that may be predominantly ther-
`apeutic or primarily diagnostic. Mar-
`gulis emphasized the need for special
`training,
`technical
`skills,
`clinical
`knowledge, ability to care for patients
`before, during, and after the proce-
`dure, and close cooperation with sur-
`geons and internists as requirements
`for performance of interventional ra-
`diologic procedures. He also raised
`questions of obligatory training of in-
`terventional radiologists in surgical
`techniques. High-quality radiologic
`imaging equipment was another of his
`basic requirements for performance of
`interventional radiologic procedures
`(6).
`Dotter was not enthusiastic about
`the term “interventional,” calling it
`imperfect. His main reservation about
`the term “interventional” was its lack
`of definition of our work. He believed
`that this term leads to confusion about
`what we do among the lay public and
`many physicians. Dotter himself de-
`fined interventional radiology as a va-
`riety of percutaneous image-guided
`alternatives or aids to surgery. How-
`ever, he realized that generalized use
`of the term “interventional radiology”
`allowed definition of a new subspe-
`cialty in radiology and separated it
`
`from general radiology and its other
`subspecialties.
`
`THE EARLY YEARS OF
`INTERVENTIONAL
`RADIOLOGY
`The most exciting years of our pro-
`fessional lives were from the late 1960s
`to the mid 1980s. Dotter’s papers, his
`lectures, and, later, daily work with
`him were constant inspirations to us
`that changed our orientation from di-
`agnostic angiographers to interven-
`tionalists. We can still hear his voice
`telling us that, whenever examining
`the patient, we must not only concen-
`trate on improving diagnoses, but we
`must also always think about potential
`ways to percutaneously treat what-
`ever we find. We and many other in-
`terventional pioneers worked hard at
`it. In the earlier years, new techniques
`were often introduced as treatments in
`patients without experimental testing,
`particularly when no other options
`were available. Emergencies found us
`prepared to innovate. In our depart-
`ment, introduction of PTA and arterial
`embolization of upper gastrointestinal
`bleeding were introduced in this man-
`ner. Applications of our experience
`and techniques in one organ system to
`a completely new organ system or
`
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`844 (cid:127) The Birth, Early Years, and Future of Interventional Radiology
`
`July 2003 JVIR
`
`loon inside a Teflon catheter with lon-
`gitudinal slits (9). This device did not
`find wide application. However, a bal-
`loon catheter made of polyvinyl chlo-
`ride introduced by German cardiolo-
`gist Andreas Grüntzig
`in
`1974
`revolutionized PTA (Fig 4) (10). Real-
`izing the potential of these balloons,
`medical device manufacturers rapidly
`placed them into production and bal-
`loon PTA took off. Favorable experi-
`ence with Grüntzig balloon catheters
`in femoropopliteal and iliac arteries
`opened the way for balloon PTA of
`other vessels. Grüntzig performed the
`first successful balloon dilations of
`coronary arteries in 1976 (11).
`Success of PTA in Europe ignited
`the interest of the new generation of
`angiographers in the United States.
`Some went to Europe to see Grüntzig
`at work at live case demonstrations he
`organized, and some even stayed with
`him for fellowships. Upon returning,
`they brought the improved PTA pro-
`cedure back to the United States,
`where it originated approximately 15
`years before. Enthusiastic work of
`these pioneers, including Barry Kat-
`zen, David Kumpe, Amir Motarjeme,
`Ernie Ring, Don Schwarten, Tom Sos,
`Charles Tegtmeyer, and others, helped
`with the rapid dissemination of bal-
`loon PTA in the United States, where it
`soon became the most commonly per-
`formed interventional procedure (Fig
`5).
`
`LOCAL THROMBOLYSIS
`Dotter introduced catheter-directed
`thrombolysis in 1972 at the annual
`meeting of the Radiological Society of
`North America in Chicago. The ori-
`gins of the procedure were the treat-
`ment of complications of angiography
`and PTA. Thrombotic occlusions occa-
`sionally occurred at the catheter en-
`trance or dilation sites because of the
`large size of diagnostic coronary cath-
`eters (8 F) and coaxial dilation cathe-
`ters (12 F). Dotter wanted to treat these
`complications with
`interventional
`techniques rather than have the pa-
`tient undergo surgery. In our depart-
`ment, we were familiar with throm-
`bolysis because of randomized studies
`comparing systemic application of
`streptokinase (SK) and heparin for
`treatment of pulmonary embolism and
`acute deep venous thrombosis. We
`were working closely with Arthur Sea-
`
`Figure 4. From left to right, Eberhardt Zeitler, Andreas Grüntzig, and Charles Dotter in
`1975 discussing angioplasty techniques at the symposium in Cologne, Germany.
`
`Reporters visiting Oregon Health and
`Science University to write about the
`Starr-Edward cardiac valve were told
`about a new procedure, PTA. They in-
`sisted on catching Dotter in action.
`Charles’ emotions and reactions to
`various stages of the procedure were
`successfully captured in pictures. The
`article, when published, resulted in
`tremendous exposure for Charles and
`PTA and also earned him the nick-
`name of “Crazy Charlie.” This na-
`tional publicity attracted a wealthy
`VIP patient, the wife of the owner of a
`large international company in New
`York City. Dotter flew to New York
`with his team and successfully treated
`this patient’s SFA stenosis. After-
`wards, the thankful patient donated
`$500,000 to the Oregon Health and Sci-
`ence University radiology department.
`Dotter used this grant to purchase up-
`to-date angiographic equipment that
`allowed him to perform PTA and
`other angiographic procedures very
`efficiently. The remaining funds Dot-
`ter used for publicity for PTA, lectures
`abroad, and to support a 1-year re-
`search fellowship in Portland for Josef
`Rösch, whom he had met at the 1963
`Czechoslovak Radiological Congress.
`However, general recognition of
`PTA progressed slowly. In particular,
`acceptance in the United States stalled
`
`for a long time. Even though Dotter
`published 17 papers on PTA in the
`first 4 years—seven in radiology jour-
`nals, four in surgery journals, one in a
`cardiology journal, and five in general
`journals—PTA procedures
`in the
`United States were performed almost
`exclusively in Portland. Angiogra-
`phers at other US institutions did not
`share Dotter’s idea of “catheter thera-
`py.” They continued to concentrate
`only on diagnosis. However, Euro-
`pean angiographers were more pro-
`gressive at
`that
`time and demon-
`strated a desire to change and expand
`their work. Werner Porstmann, a good
`friend of Dotter from Berlin, started
`performing PTA in the mid 1960s and
`published his first experience in 1967
`(6). Van Andel from The Netherlands
`modified the dilation catheters. How-
`ever, the greatest credit for dissemi-
`nating PTA throughout Europe be-
`longs
`to Eberhart Zeitler
`from
`Germany (Fig 4). Thanks to his work,
`many European angiographers ac-
`cepted PTA and began “Dottering”
`diseased arteries (7,8).
`The Europeans also made critical
`steps in PTA development by intro-
`duction of clinically applicable balloon
`catheters. The first “caged” or ”corset“
`balloon catheter described by Ports-
`man in 1973 consisted of a latex bal-
`
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`Volume 14 Number 7
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`Rösch et al (cid:127) 845
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`Figure 5. The pioneers of balloon PTA in the United States. From left to right, upper row:
`Barry Katzen, David Kumpe, Amir Motarjeme, Ernie Ring. Lower row: Donald
`Schwarten, Thomas Sos, Charles Tegtmeyer.
`
`Figure 6. One of the first cases of local thrombolysis performed in June 1972 (reprinted
`with permission from reference 12).
`
`man, an experienced hematologist in
`this area. In addition, we had exten-
`sive experience with local arterial in-
`fusion therapy, mainly with vasopres-
`sin infusions for control of arterial and
`variceal gastrointestinal bleeding and
`chemotherapy infusions for treatment
`of tumors.
`It was a natural beginning. As soon
`
`as the complication was recognized,
`an end-hole catheter was placed just
`above a short thrombus or a multiple–
`side hole catheter was thrust into a
`long thrombus in the angiography
`room. Continuous SK infusion was
`then performed in the intensive care
`unit. The dose of SK most often used
`was 5,000 U/h infused into the iliac or
`
`Figure 7. Dotter’s early followers in local
`thrombolysis. From left to right, upper
`row: Barry Katzen, Arina Van Breda.
`Lower
`row: Gary
`Becker,
`Thomas
`McNamara.
`
`femoral arteries, approximately 5% of
`the usual systemic dose. Portable an-
`giograms at 12- or 24-hour intervals
`were used to monitor the progress of
`fibrinolysis. In the first six patients
`with acute thrombosis, 18–112-hour
`infusions
`(mean, 47 hours) were
`needed for complete clot lysis (Fig 6)
`(12). Encouraged by good results with
`acute thromboses, Dotter explored lo-
`cal SK infusions in chronic arterial oc-
`clusions, but
`found only minimal
`benefit for this indication. Therefore,
`we continued local thrombolysis for
`our occasional complications. Some-
`times we used thrombolysis before
`PTA when there was clinical suspi-
`cion of acute or subacute thrombosis
`superimposed on chronic arterial
`obstruction.
`Our publication on this technique
`in April 1974 did not generate enthu-
`siasm for local thrombolysis among in-
`terventionalists. The need for hospital-
`ization in the intensive care unit, the
`antigenic nature of SK, and some
`bleeding complications were probably
`the main factors for the limited accep-
`tance of this technique. Barry Katzen
`and Arina Van Breda were the first
`followers in the United States and, in
`1981, they published their experience
`and found local SK infusion beneficial
`
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`846 (cid:127) The Birth, Early Years, and Future of Interventional Radiology
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`grams more than 2 years after place-
`ment. The coil springs Dotter used
`were not expandable, but he sug-
`gested a mechanism for their expan-
`sion. “Coil springs, either stretched
`out or wound up and hooked to a
`controlling mandrel, can be reduced in
`diameter favoring their easy introduc-
`tion and placement. Upon their exter-
`nally effected release from the man-
`drel, they automatically expand to a
`bigger lumen and better anchoring at
`the site of placement.” Only later did
`Dotter call these endarterial prosthe-
`ses stents.
`It took more than 10 years before
`Dotter’s idea of endovascular stent
`placement became established in inter-
`ventionalists’ minds. But, when there,
`rapid progress followed. Several types
`of new expandable stents were intro-
`duced and tested in animals and most
`of them were eventually used in clin-
`ical practice. Early on,
`they were
`mostly handmade and used with local
`institutional review board approval.
`Later on, when companies obtained
`approval for their use in the biliary
`system, they were placed intravascu-
`larly on an off-label basis. More than
`30 years after Dotter’s original experi-
`ments, only a small number of stents
`have been approved by the Food and
`Drug Administration for intravascular
`use.
`The Swiss surgeon Dierk Maass
`headed a line of creative inventors,
`mainly interventional radiologists in-
`cluding Dotter, Andrew Cragg, Cesare
`Gianturco, and Julio Palmaz, who, in
`the early and mid 1980s, introduced a
`variety of expandable metallic stents.
`These were either self- or balloon-ex-
`pandable stents made primarily of
`stainless-steel alloys or thermal mem-
`ory stents made of nitinol, an alloy of
`nickel and titanium. Maass self-expand-
`able spiral coils and double-helix stents,
`introduced in 1982, were studied in
`animals and later used in clinical prac-
`tice, mainly for relieving inferior vena
`cava obstructions and, occasionally, in
`aortic dissections (17,18). These de-
`vices never gained widespread accep-
`tance mainly because their large intro-
`ducing
`sheaths
`required arterial
`cutdown.
`Nitinol stents were introduced in
`1983 when Dotter and colleagues (19)
`and Cragg and colleagues (20) simul-
`taneously published results of their
`experimental studies (Fig 9). With
`
`Figure 8. Coil spring endarterial tube graft and its percutaneous placement introduced
`by Charles Dotter in 1969 (reprinted with permission from reference 16).
`
`Figure 9. Charles Dotter (left) and Andrew Cragg (right) and their nitinol stents (stents
`reprinted with permission from references 19 and 20).
`
`in acute thromboses and before bal-
`loon PTA (Fig 7) (13). Gary Becker and
`colleagues confirmed their results in a
`larger number of patients (14). How-
`ever, local thrombolysis did not be-
`come widely accepted until SK was
`replaced by urokinase, a safer fibrino-
`lytic agent that is relatively nonanti-
`genic, with better probability of pre-
`dicting therapeutic dose responses.
`Tom McNamara published the first
`large series of patients treated with
`local urokinase infusions and his ded-
`icated efforts helped to spread local
`urokinase fibrinolysis into interven-
`tional practice (Fig 7) (15).
`
`EXPANDABLE STENTS
`
`Dotter started the era of intravascu-
`lar stent placement in 1969 with the
`introduction
`of
`a
`transluminally
`placed coil spring endarterial tube graft
`(Fig 8) (16). Frustrated with the fre-
`quently occurring occlusions of a re-
`canalized SFA, he tried to find a per-
`cutaneous method to keep the artery
`open. Of several different types of per-
`cutaneously introduced tubings, only
`the uncoated coil spring tubular pros-
`theses stayed open in canine SFAs.
`Two of three 1-cm-long coil springs
`remained patent on follow-up angio-
`
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`Rösch et al (cid:127) 847
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`saline solution during introduction.
`These complex introduction systems,
`together with significant intimal pro-
`liferation of the stent-implanted ca-
`nine iliac and femoral arteries, were
`drawbacks to the use of nitinol stents
`in the United States in the 1980s and
`early 1990s. In Russia, Josef Rabkin in-
`troduced a widely spaced nitinol spiral
`stent that was easy to introduce and that
`expanded at body temperature. After
`experimental animal testing, he used it
`in clinical practice beginning in 1985. In
`the early 1990s, he reported successful
`results in treatment of obstructions in
`vascular and nonvascular systems in
`268 patients (21).
`Three stents were introduced in
`1985: the Gianturco Z stent, Palmaz
`stent, and Wallstent. The self-expandable
`Gianturco Z stent (Fig 10), made from
`stainless-steel wire bent into a zigzag
`pattern with connected ends, had a
`strong expansile force (22). To prevent
`overexpansion of the stent-implanted
`structures and to maintain the desired
`diameter, we modified the original Z
`stent by suturing its bent “eyes” with
`monofilament (23). This also allowed
`us to form multisegmental stents and
`facilitate their placement. It was easy
`to make both the original and modi-
`fied Z stents by hand. Many interven-
`tionalists in the United States and
`abroad made them at home before
`they became available from manufac-
`turers. We often used modified Z
`stents for relief of obstructions of large
`veins, particularly the superior and in-
`ferior venae cavae (24). One of our
`patients with occlusion of the inferior
`vena cava and common iliac veins and
`enormous edema treated with stent
`placement in 1990 is still alive without
`edema recurrence. The simple zigzag
`pattern of the Z stent has been incor-
`porated into frames of several types of
`aortic stent-grafts.
`Palmaz made his original balloon-ex-
`pandable stent under a low-power mi-
`croscope by weaving stainless-steel
`wire into a crisscrossed tubular pat-
`tern and then electropolishing it. The
`crossover points were soldered to
`keep the stent expanded after balloon
`inflation (25). Soon, however, the pro-
`cess was modified for easier fabrica-
`tion and his final stent design became
`a single stainless-steel tube with par-
`allel staggered slots in the wall (Fig 11)
`(26). We had the opportunity to use
`homemade Palmaz stents for our ex-
`
`Figure 10. Cesare Gianturco (left) and Hans Wallsten (right) and their self-expandable
`stents (Wallstent reprinted with permission from reference 28).
`
`Julio Palmaz and his balloon-expandable stent (stent reprinted with permis-
`Figure 11.
`sion from reference 26).
`
`Dotter’s nitinol spiral stent, saline so-
`lution heated to 60°C was needed for
`rapid radial stent expansion after its
`
`placement. Cragg’s body tempera-
`ture–activated nitinol coil graft for ex-
`pansion required flushing with cool
`
`Edwards Lifesciences Corporation, et al. Exhibit 1016, p. 7 of 13
`
`

`

`848 (cid:127) The Birth, Early Years, and Future of Interventional Radiology
`
`July 2003 JVIR
`
`placement, the membrane was with-
`drawn, freeing it and allowing stent
`expansion. After Schneider Europe
`started manufacturing the Wallstent
`with a simplified unsheathing deliv-
`ery system and markers, the Wallstent
`became very popular in Europe and
`was used not only in vascular systems,
`including coronary arteries and TIPS,
`but also in nonvascular applications
`(27,28). Good results in Europe with
`the Wallstent brought it to the United
`States. Thanks to several clinical inves-
`tigators including the interventional
`team at the University of California,
`San Francisco, Wallstents were soon
`approved for biliary use and later for
`other applications.
`
`ACUTE GASTROINTESTINAL
`BLEEDING
`Angiographic diagnosis and treat-
`ment of acute gastrointestinal bleed-
`ing (AGIB) was pioneered by Stanley
`Baum and Moreye Nusbaum in the
`1960s. First, they showed in 1963 that
`selective visceral cut-film arteriogra-
`phy was capable of demonstrating ex-
`travasation at rates as low as 0.5 mL/
`sec (29). Then,
`in 1967, after they
`found in animal experiments that va-
`soconstrictive infusion of the superior
`mesenteric artery could reduce portal
`hypertension (30), they started to use
`continuous low-dose vasopressin infu-
`sion in clinical practice for control of
`variceal bleeding (Fig 12) (31). Since
`that time, diagnosis and treatment of
`AGIB has become an important part of
`an interventionalist’s work.
`In the
`1960s and early 1970s, when emer-
`gency endoscopy had not been widely
`adopted, selective and superselective
`visceral arteriography was the pri-
`mary procedure in the diagnosis of
`AGIB. The role of interventionalists
`further increased when they became
`involved with AGIB treatment. We
`still remember the many night, week-
`end, and holiday emergency calls and
`seeming AGIB epidemics during
`Christmas and New Year’s time. Nev-
`ertheless, it gave us great satisfaction
`when we were able to pinpoint the
`source of bleeding and stop the
`hemorrhage.
`In 1968, we started with short selec-
`tive infusions of epinephrine into the
`bleeding artery preceded by low-dose
`propranolol injection to block its ␤-ad-
`renergic effect in the treatment of ar-
`
`Figure 12. Stanley Baum (left) and Moreye Nusbaum (right) in the mid 1960s reviewing
`an angiographic procedure.
`
`Figure 13. First case of selective arterial embolization of arterial treatment performed by
`Josef Rösch in November 1970. Selective angiograms before embolization and after
`embolization (angiograms reprinted with permission from reference 33).
`
`perimental TIPS research in pigs, and
`they worked very well. Palmaz did
`excellent research work with his stents
`and their use in the arterial system
`including peripheral, renal, and coro-
`nary arteries, and in TIPS. His stent
`was the first and, for a long time, the
`only stent approved by the Food and
`Drug Administration for vascular use.
`Palmaz also studied biomechanical
`and hemodynamic effects of stents in
`various arteries and contributed sig-
`nificantly to our understanding of ar-
`terial stent placement.
`
`The self-expanding spring-loaded
`meshwork stent known now as the
`Wallstent was developed by engineer
`Hans Wallsten at his Swiss company,
`Medinvent (Fig 10). With use of the
`technique known from other applica-
`tions such as making braids in cathe-
`ters or coaxial cable shielding, Wall-
`sten spun 16–20 alloy spring filaments
`into a tubular, flexible, self-expanding
`braid configuration. The stent was
`then constrained on a small-diameter
`catheter by a rolling membrane for
`easy vascular introduction. For stent
`
`Edwards Lifesciences Corporation, et al. Exhibit 1016, p. 8 of 13
`
`

`

`Volume 14 Number 7
`
`Rösch et al (cid:127) 849
`
`tion in 1972, we did a series of canine
`experiments and found that the com-
`bination of vasoconstrictive infusions
`and clot embolization was effective
`and did not cause infarction because
`of multiple visceral collaterals (33).
`After our case publication, selective
`arterial embolization became rapidly
`accepted to control acute arterial
`bleeding. After several attempts to use
`modified autologous clots (34), surgi-
`cal gelatin (Gelfoam; Upjohn, Kalama-
`zoo, MI) became the embolization ma-
`terial of choice (35). It was mostly
`used as pieces cut from surgical pads
`for more central embolization. We
`also occasionally used Gelfoam pow-
`der for peripheral embolization, par-
`ticularly for diffuse
`small-vessel
`bleeding in erosive gastritis to pre-
`vent bleeding from multiple gastric
`collaterals (36).
`For control of variceal bleeding, we
`started in 1970 with continuous low-
`dose vasopressin infusion into the supe-
`rior mesenteric artery, as introduced
`by Baum and Nusbaum (31). After ex-
`clusion of an arterial bleeding source,
`a 20-minute vasopressin infusion was
`performed in the angiography labora-
`tory to evaluate its effectiveness. Con-
`tinuous 2–4-day infusion then fol-
`lowed in the intensive care unit.
`Vasoconstrictive infusions were rea-
`sonably successful and controlled
`bleeding in approximately 60%–70%
`of patients with only minor to moder-
`ate local and systemic complications.
`However, these selective infusions fell
`into disfavor after studies in our re-
`search laboratory showed that they
`have no better effect on portal and
`systemic hemodynamics than low-
`dose systemic infusions, which was
`later confirmed by randomized clini-
`cal studies.
`Another factor in decreasing the
`use of selective vasoconstrictive ther-
`apy was the introduction of a new
`interventional method,
`transhepatic
`variceal embolization, by Anders Lun-
`derquist in 1974 (Fig 14) (37). With a
`transhepatic portal
`approach,
`the
`veins supplying varices were selec-
`tively catheterized and embolized to-
`gether with varices. We were very ac-
`tively involved with this technique
`and preferred isobutyl 2-cyanoacry-
`late or Gelfoam mixed with sodium
`tetradecylsulfate, sometimes preceded
`with Gianturco coil placement to slow
`flow in large varices, as our embolic
`
`Figure 14.