J ENDOVASC THER
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`^HISTORICAL PERSPECTIVE —————————————————————————— ^
`
`The First Steps in Endovascular Aortic Repair:
`How It All Began
`
`Nikolay L. Volodos, MD
`
`Centre of Cardiovascular Surgery, Kharkov, Ukraine.
`
`In my opinion, there were two main factors
`that contributed to my interest in the devel-
`opment of endografting of the aorta and its
`main branches. First of all, fate helped me to
`become one of the disciples of the founder of
`vascular surgery in the Ukraine, the academi-
`cian Alexander Alekseevich Shalimov, who
`was a talented, very progressive man who
`strove for innovations. Dr. Shalimov deter-
`mined my professional career;
`in 1962 he
`assigned me to work on the surgical treat-
`ment of ischemic heart disease, a therapy that
`had just started to develop all over the world.
`We performed coronary angiography and
`coronary artery surgery on dogs in very
`primitive conditions. But most importantly,
`we closely followed progress in that area
`abroad, mainly the work done by American
`doctors. We learned about, and enjoyed, the
`achievements of outstanding innovative phy-
`sicians, such as Charles Dotter from Portland,
`Oregon, with his methods of coronary angi-
`ography, and the work of Donald B. Effeler
`from Cleveland, Ohio, on coronary artery
`surgery in dogs.
`In 1965, Dr. Shalimov
`founded the first specialized department of
`vascular surgery in the Ukraine, and I was its
`first chief.
`The second main factor was the unusual
`conditions under which vascular surgery in
`our country developed.
`In the Ukraine, a
`vascular surgeon was both a surgeon and an
`angiography specialist at the same time. We
`personally performed all kinds of angiograph-
`ic research. For example,
`in Kharkov,
`I
`
`performed the first 440 coronary angiogra-
`phies, and later I operated on some of those
`patients. My 1971 PhD dissertation was
`dedicated to the topic: ‘‘Coronary Angiogra-
`phy and Surgery of Coronary Arteries.’’ My
`second dissertation (1988)
`for a doctoral
`degree was on acute arterial pathology,
`in
`which one of the chapters was dedicated to
`the development of what we called at that
`time remote endoprosthetics (i.e., stent-graft-
`ing).
`Before going into the specific details con-
`cerning the development of stent and stent-
`graft technology in the Ukraine, I would like to
`give credit to some of the co-workers who
`helped bring our ideas to fruition. In our early
`years together, we had developed productive,
`friendly relationships with the leading techni-
`cal, scientific, and research institutes and
`large industrial enterprises in Kharkov. They
`helped us design and manufacture many
`medical tools and devices for cardiovascular
`surgery, since the domestic medical industry
`was unable to keep up with the scientific
`progress.
`In the 1980s, Kharkov was the largest
`industrial center of the Ukraine, which is why
`I consider the design and manufacture of all
`elements for endovascular stent-grafting to be
`the result of a joint effort between the medical
`team under my leadership (Ivan Pavlovich
`Karpovich, Vladimir Ivanovich Troyan, and
`Julia Valentinovna Kalashnikova) and the
`industrial engineers of Kharkov to whom I
`am obliged: Vasily Egorovich Shehanin, aca-
`
`Solicited articles published in the Journal of Endovascular Therapy reflect the opinions of the author(s) and do not
`necessarily represent the views of the Journal or the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS.
`
`Corresponding author: Nikolay L. Volodos, MD, Centre of Cardiovascular Surgery, ave. Lenina 64, flat 12, Kharkov
`61103, Ukraine. E-mail: volodos@ilt.kharkov.ua; nikolayvolodos@gmail.com; kalashnikova.jv@gmail.com
`
`Q 2013 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS
`
`Available at www.jevt.org
`
`MEDTRONIC 1131
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`Figure 1 ^ (A) The first special device for the manufacture of zigzag springs. (B) The first construction of the
`stent (1982). (C) Optimal variant of stent construction (1983).
`
`demician Boris Ieremievich Verkin, Professor
`Nikolay Emmanuilovich Ternuk, Anatoly Se-
`menovich Neoneta, Aleksander Aleksandro-
`vich Aksenko, Leonid Fedorovich Yakovenko,
`Mikhail Semenovich Gurnak, Leonid Stepano-
`vich Keremet, Nicholay Ivanovich Ustinov,
`and others.
`
`LOOKING FOR A MINIMALLY
`INVASIVE THERAPY
`
`The challenges associated with treating pa-
`tients with serious comorbidities and ruptured
`abdominal aortic aneurysms (AAA) or acute
`thrombosis of the abdominal aorta pushed us
`to search for a less traumatic treatment
`
`Figure 2 ^ Our patent for a stent-graft (USSR
`Patent 1217402, issued in May 1984).
`
`method. We turned to Dotter’s idea, which
`he reported in 1969,1 and in 1982 started to
`look for a structure that could give a prosthe-
`sis a self-fixating quality, something that we
`considered to be the key to achieving a
`minimally invasive therapy.
`By the beginning of 1983 a strategy had
`been developed and directions were outlined.
`The main step forward was the design and
`manufacture of a Z-shaped stent. In searching
`for the most suitable material, we chose an
`elastic wire made of stainless steel
`(40KHN10MTYUVI; Bauman Moscow State
`Technical University, Moscow, Russia). To
`connect
`the ends of
`the wire, extensive
`mechanical studies were conducted, including
`various methods of welding, among which
`spot-welding proved to be the most suitable.
`We designed and produced a special device
`(Fig. 1A) for the manufacture of the zigzag
`stents. Over the course of our work, the device
`evolved from a primitive 2-level structure of
`bent wire (Fig. 1B) to the optimal version (Fig.
`1C), which was protected by a USSR patent in
`May 1984 (Fig. 2), 5 months earlier than the
`Gianturco patent.
`Since the stent was fundamentally a new
`geometric figure, it was necessary to study its
`properties. Firstly, the radial forces produced
`by the Z-shaped stent had to be calculated. To
`do this, we designed a special test apparatus
`that began as a primitive device with dead
`weights and evolved to precision instruments
`(Fig. 3), such as gramometers. Physicists
`calculated on a theoretical basis the elastic
`properties that
`the Z-shaped stents would
`need to hold the prosthesis: ~0.2 g/mm2. A
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`Figure 3 ^ The evolution of devices for studying the radial forces produced by a Z-shaped stent.
`
`nomograph was developed to help us choose
`the wire diameter and number and height of
`the zigzags in a stent depending on the
`diameter of
`the vessel. Based on this re-
`search, a self-fixating synthetic prosthesis
`was produced by placing a Z-stent
`in a
`standard Dacron synthetic graft (Sever, Lenin-
`grad, Russia). The crimps were removed by
`boiling and stretching the prosthesis. The Z-
`
`the
`stent was placed into the lumen of
`prosthesis and attached with thin atraumatic
`sutures (Fig. 4).5
`The next major challenge was to determine
`the magnitude of the radial force necessary to
`hold the prosthesis in the aorta. We also
`needed to identify the behavior of the endo-
`prosthesis under conditions of pulsatile flow,
`as well as study the reliability of its fixation
`and calculate the dislocation forces. For this
`purpose, a series of experiments (Fig. 5) were
`performed on cadaveric aortic segments in
`
`Figure 4 ^ The first variant of
`endoprosthesis.
`
`the self-fixing
`
`Figure 5 ^ Schematic drawing of a pulsatile flow
`apparatus to study endoprostheses in cadaveric
`aortic segments.
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`transportation component was made of poly-
`tetrafluoroethylene (PTFE), which was intro-
`duced using a guidewire and a catheter into
`the aorta through a peripheral artery. At the
`distal end of the transportation component,
`there was a docking device with a valve to
`ensure hemostasis. The loading component,
`also made of PTFE, compressed the endo-
`prosthesis to several times its nominal diam-
`eter by means of special cone devices. The
`compressed endoprosthesis was then moved
`out of the loading component, through the
`docking device, and into the transportation
`component using a pusher, a flexible or rigid
`metal rod placed immediately behind the
`proximal stent. During the initial stage of our
`work, we attached great importance to rigid
`fixation of the delivery system, which was
`achieved by mounting the delivery system on
`a special metal frame attached to the operat-
`ing table (Fig. 6C).6,9,11 We felt that this would
`guarantee exact placement of the endopros-
`thesis in the aorta.
`It was obvious that for a firmer contact, it
`was necessary to dilate the endoprosthesis
`from inside. For this purpose, a special
`balloon was developed and manufactured. It
`consisted of a dual channel radiopaque
`catheter connected at the end to a cylinder,
`the wall of which consisted of 3 layers: 2 outer
`ones made of latex rubber and a middle one
`made of a non-elastic fabric (Fig. 7A) that
`would guarantee a given diameter during
`balloon inflation (Fig. 7B),
`thus creating a
`non-compliant balloon.7,8,12
`In those days,
`there were no computed
`tomography scanners, so to precisely mea-
`sure the diameter of the vessels in which the
`stent-graft would be implanted, we designed
`and manufactured a special measuring cath-
`eter with graduated long metal markers
`placed 10 mm apart (Fig. 8).6,55
`Having done the theoretical and experimen-
`tal work, we decided that it was now possible
`to carry out experiments on animals. After
`making all of
`the above mentioned items
`between 1983 and 1984, experimental re-
`search was performed on big dogs (25–30
`kg). The diameter of the aorta was determined
`using aortography and the measuring cathe-
`ter. The endoprosthesis was introduced from
`the femoral artery and delivered into the
`
`Figure 6 ^ (A) Schematic drawing of our first
`delivery system. (B) One of the variants of the
`joining unit of our experimental delivery system.
`(C) Special metal frame attached to the operating
`table for fixation of the delivery system.
`
`which endoprostheses had been placed; a
`heart-lung machine was used to achieve
`pulsatile flow under physiological conditions.
`The experiments confirmed the theoretical
`calculations; the stent must develop a radial
`force of 0.2 g/mm2 in order to achieve stable
`fixation in the aorta.
`About the same time, it became clear that
`delivering the endoprosthesis into the thorac-
`ic or abdominal aorta from the femoral artery
`would require a special delivery system. Our
`first delivery system (Fig. 6A), which was also
`patented, consisted of 3 parts: the loading
`part, the transportation component, and the
`docking device (Fig. 6B) to connect them.6 The
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`Figure 8 ^ Our special measuring catheter.
`
`was also submerged in a similar tissue,
`through which the wire struts could be seen
`(Fig. 9B).
`With the new method of placing endopros-
`theses, we considered a thorough study of
`morphological changes in the vessel walls
`where the device was seated to be of
`paramount importance. The intima along the
`entire length of the endoprosthesis was inlaid
`with thickened endothelium and consisted of
`collagen fibers oriented concentrically on the
`cross section of
`the vessel, with spindle-
`shaped fibrocytes and smooth muscle cells
`enclosed between them (Fig. 9C). The neoin-
`tima thickness was 0.25 to 0.65 mm. In the
`zone where the struts of
`the stent were
`located, neointima of
`the endoprosthesis
`was thicker: 0.39 to 0.58 mm. Under the
`prosthesis, the native intima of the aorta was
`thickened, and newly-formed vessels of a
`sinusoid type and capillaries were seen (Fig.
`9D). In the media of the aorta, hyperplasia of
`elastic fibers was observed. The adventitia
`was somewhat
`thickened,
`the number of
`histiocytes was increased, and the elastic
`fibers were thickened. Thus, placing the
`endoprosthesis inside a vessel
`led to an
`anticipated reaction of
`the aorta, with the
`formation of neointima due to the growth of
`structural elements of the native intima in
`response to excitation.3 These experiments
`demonstrated the functionality of the Z-stent
`
`Figure 7 ^ (A) Schematic diagram of our balloon
`catheter construction. (B) The balloon catheter is
`ready for use. (C) The balloon catheter is inflated
`maximally.
`
`abdominal aorta using our delivery system.
`Finally, the endoprosthesis was seated with
`the help of our non-compliant balloon cathe-
`ter. Fifteen experiments were performed; all
`the dogs survived and were monitored for 6
`months. Every 2 months aortography was
`performed. There was no evidence that the
`endoprostheses shifted or dislocated (Fig. 9A)
`and all remained patent. After 6 months, the
`dogs were sacrificed. Macro- and microscopic
`examinations of the vessel wall were per-
`formed in the aortic segment in which the
`endoprosthesis was located. Macroscopically,
`the inner surface of the endoprosthesis along
`its entire length was covered with a grayish
`semitransparent
`tissue forming a kind of
`intima identical to the intima of an elastic-
`type vessel, with a smooth shiny surface that
`we tentatively called neointima. The Z-stent
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`Figure 9 ^ (A) Radiograph 6 months after stent implantation in a dog, showing stable position of the
`endoprosthesis. (B) Macroscopic view of the stent submerged into the neointima. (C) Microscopic view inside
`of the endoprosthesis; the intimal lining has a thickened endothelium and consists of collagen fibers oriented
`concentrically on the cross section of the vessel, with spindle-shaped fibrocytes and smooth muscle cells
`enclosed between them. (D) Aortic intima under the endoprosthesis, showing a thickened intima with newly-
`formed vessels.
`
`as a fixating mechanism for the prosthesis
`and also good biocompatibility. The results of
`these experimental studies were presented at
`conferences in our country (Moscow, Irkutsk,
`Tallinn) from 1985 onward.2–4
`
`FROM THE LABORATORY TO THE
`OPERATING ROOM
`
`The experimental work allowed us to move on
`and apply the method of endografting in
`clinical settings. The basic design of
`the
`delivery system (Fig. 10) for clinical use was
`the same as in the experimental prototype,
`
`but the PTFE tubes for clinical use had an
`outer diameter of 8 mm, whereas the exper-
`imental ones were 6 mm.
`Our first case of endoprosthetic surgery
`(stent-grafting) was done on May 4, 1985.5,6
`The 66-year-old man was admitted to the
`vascular surgery department with a 6-year
`history of left foot ischemia that had pro-
`gressed to cause rest pain and a trophic ulcer
`on the big toe; he had not responded to
`conservative treatment. Comorbidities includ-
`ed severe ischemic heart disease with ar-
`rhythmia. On examination there was an
`audible systolic murmur over the iliac artery.
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`anastomosis to the deep femoral artery. A
`stent-graft was delivered to the external iliac
`artery via a longitudinal arteriotomy of the
`common femoral artery. The proximal end of
`the endoprosthesis, with the stent, was posi-
`tioned in the common iliac artery and the
`distal end was anastomosed end-to-end into
`the newly formed bifurcation between the
`venous bypass and the deep femoral artery.
`Blood flow in the endoprosthesis was re-
`stored. Completion angiography (Fig. 11C)
`showed a well functioning endoprosthesis.
`The reconstruction functioned well for 1 year,
`until the patient died from a stroke.
`In March 1987, we performed the very first
`transfemoral stent-graft procedure to treat a
`post-traumatic aneurysm of the thoracic aorta
`in a 53-year-old man.6,10 On admission, the
`patient presented with chest pain, weakness,
`and dyspnea under physical strain. Notably,
`the patient was involved in a car accident in
`1959, which resulted in a compression frac-
`ture of T12 and paraplegia. On April 15, 1986,
`the patient underwent a left thoracotomy for a
`left-sided pulmonary mass, which was subse-
`quently confirmed to be a pulsating aneu-
`rysm. The chest was closed, and the patient
`was transferred to the vascular unit. On
`thoracic aortography (Fig. 12A), a pseudoan-
`eurysm was seen in the descending thoracic
`aorta. It was circular in shape and measured
`635 cm in diameter. The aortic segment
`above the pseudoaneurysm was stenotic,
`with a minimum diameter of 11 mm, whereas
`the diameter of the aorta below the aneurysm
`measured 20 mm.
`On March 24, 1987, we performed a remote
`transfemoral stent-graft procedure of the tho-
`racic aorta using a self-fixating synthetic pros-
`thesis (Fig. 12B). Under general anesthesia in
`the angiographic suite,
`the right common
`femoral artery was exposed. The stenotic aortic
`segment was dilated with an 18-mm balloon.
`Under fluoroscopic control, the self-fixating
`synthetic prosthesis was inserted, positioned,
`deployed, and dilated with a 24-mm balloon. In
`this patient,
`the stent-graft had 2 fixating
`elements (stents) at the ends; the upper stent
`was located at T8 and the lower at the level of
`T12. Completion aortography (Fig. 12C) showed
`that the endoprosthesis was positioned as
`planned and that the pseudoaneurysm was
`
`Figure 10 ^ (A) Elements of the first delivery
`system for use in the clinic. (B) The first delivery
`system for clinical use in the assembly.
`
`The preoperative angiogram (Fig. 11A,B)
`demonstrated significant stenosis at the tran-
`sition of the left common iliac artery to the left
`external iliac artery and occlusion of the left
`internal iliac artery, superficial femoral artery,
`and the popliteal artery. Below the knee, only
`the posterior tibial artery was patent.
`A 2-step reconstructive procedure was
`proposed based on the nature of the athero-
`sclerotic disease and the degree of
`limb
`ischemia. At surgery, the left posterior tibial
`artery was exposed under general anesthesia.
`A reversed long saphenous vein bypass was
`fashioned with an end-to-side anastomosis to
`the posterior tibial artery and a side-to-side
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`Figure 11 ^ Angiograms of our first patient with (A) stenosis of the iliac artery and (B) occlusion of the
`superficial
`femoral and popliteal arteries before the procedure.
`(C) Completion angiogram after the
`procedure on May 4, 1985.
`
`completely excluded. The patient remained
`alive for the next 18 years and 3 months. During
`this time, the endoprosthesis remained stable
`(Fig. 12D), without any evidence of endoleaks,
`and the aneurysm remained excluded, as seen
`on a follow-up CT (Fig. 12E) 10 years after
`treatment. The patient died in 2005 from an
`acute myocardial infarction at the age of 71.
`Information about this first case of the remote
`replacement of traumatic thoracic aortic aneu-
`rysm was presented at meetings and in our
`publications.6,9,10,11,13–19,23,41,50,63,64,65 In 1987,
`we published a monograph dedicated to the
`results of our experimental studies and first
`clinical experience (Fig. 13).6
`In December 1989, we attempted to stent-
`graft an AAA (Fig. 14A) with a single-piece
`bifurcated endoprosthesis. The procedure was
`performed from bilateral femoral approaches
`with the use of ligatures brought across the
`aortic bifurcation and attached to the contra-
`lateral limb of the bifurcated device (Fig. 14B).
`However, a complication occurred, resulting in
`twisting of the unstented contralateral
`limb
`(Fig. 14C). The patient was converted to open
`surgery with good outcome.
`In June 1991, we performed the first hybrid
`procedure on the aortic arch, combining open
`surgery for debranching of the aortic arch and
`stent-grafting of anastomotic pseudoaneu-
`
`rysms from a previous surgery for a coarcta-
`tion.17 The 41-year-old woman had at the age
`of 23 had a coarctation repaired using a
`Dacron graft. A diagnostic angiogram done 8
`years after surgery revealed aneurysmal
`changes at both the proximal and distal
`anastomoses. A repeat angiogram 17 years
`postoperatively demonstrated a considerable
`increase in the size of the aneurysms (Fig.
`15A); the left subclavian artery was involved
`in the aneurysm at the proximal anastomosis.
`The diameter of the pseudoaneurysm of the
`distal anastomosis was .6 cm.
`The procedure began in the angiographic
`suite, where an angiographic catheter was
`passed through the left femoral artery to the
`ascending aorta. The patient was then trans-
`ferred to the operating room where a median
`sternotomy was performed. A tubular graft
`measuring 14 mm in diameter was anasto-
`mosed end-to-side to the ascending aorta.
`Using a temporary shunt from the tubular
`graft to the left common carotid artery, the
`latter was re-implanted to the brachiocephalic
`trunk. A left carotid-subclavian bypass was
`also performed. The stumps of
`the left
`common carotid artery and the left subclavian
`artery were ligated. The angiographic catheter
`inserted via the left common femoral artery
`was transferred into the lumen of the tubular
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`Figure 12 ^ (A) Preoperative aortogram of a 53-year-old patient with a post-traumatic aneurysm of the
`thoracic aorta. (B) Schematic drawing of the thoracic stent-graft procedure via a femoral approach performed
`on March 28, 1987.
`(C) Completion aortogram.
`(D) Radiograph showing the stable position of
`the
`endoprosthesis. (E) CT 10 years after the procedure.
`
`graft. In this way, a through-and-through wire
`was achieved. A special delivery system was
`inserted into the aortic arch via the tubular
`graft, such that the graft was transferred over
`the through-and-through wire from the aortic
`arch to the descending aorta by connecting
`the angiographic catheter to the delivery
`system and applying traction from below.
`Under fluoroscopic control and using traction
`from below, the endoprosthesis with 2 fixat-
`ing elements at its ends was delivered using a
`2-part delivery system (Fig. 15C) that allowed
`the endograft to be pulled from the 2 different
`access sites to aid in precise positioning in the
`aortic segment. The pseudoaneurysms were
`completely excluded. A CT examination con-
`firmed a successful outcome 16 years later
`
`(Fig. 15D). The patient is still alive 21 years
`later, in good health, with the endoprosthesis
`stable and exclusion of the pseudoaneurysms
`maintained. We reported our first experience
`of stent-graft
`implantation in the thoracic
`aorta in Toulouse in early 199014 and in the
`summer of 1991 in Essen17; information about
`the combined (hybrid) method of treating a
`thoracic aneurysm and the first report of its
`application was subsequently presented and
`published.17–20,40,42,51,52,63–65
`The successful experience of reconstructing
`the aortic arch and the descending aorta led
`us to develop a new method of stent-grafting
`the thoracic and abdominal aorta using 2
`access sites: the upper through the subclavian
`or axillary artery and the lower via the femoral
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`In addition, by providing
`thoracic aorta.
`secure fixation of the endoprosthesis, there
`was no need for induced hypotension during
`deployment.23,25,30,31,33,34,36,43
`Using this new approach, we employed the
`dual access site technique for delivery and
`placement of an endoprosthesis in the tho-
`racic aorta in 2 patients in 1993.27–31 In both
`cases, we used the axillary artery as the upper
`access and the common iliac arteries as the
`lower access. On August 19, 1993, a stent-
`graft was deployed in a 43-year-old woman
`with a traumatic aneurysm of the descending
`aorta; the patient is still alive, with excellent
`function of the stent-graft.
`The second patient was a 41-year-old man
`with a false aneurysm in the descending aorta
`following a previous patch angioplasty of a
`coarctation 26 years earlier. The patient
`presented with an aortobronchial fistula with
`pulmonary hemorrhage (Fig. 17A). A stent-
`graft (Fig. 17B) was implanted in the thoracic
`aorta to exclude the aortobronchial
`fistula
`(Fig. 17C). The endoprosthesis remained
`patent and in an unchanged position for 18
`years (Fig. 17D).57,60,61
`We began to use the same dual access
`method for stent-graft treatment of the ab-
`dominal aorta in early 1992.
`In total, we
`successfully treated 6 patients with AAAs
`using tubular endoprosthesis (Fig. 18). The
`results of this experience were reported in
`Athens at the European Society of Vascular
`
`Figure 13 ^ Our first monograph dedicated to the
`results of our experimental studies and first clinical
`experience (1987).6
`
`or iliac arteries.22,42,43,44 For these purposes, a
`special delivery system was developed and
`manufactured (Fig. 16). The new approach
`allowed the delivery system to be pulled up
`with the endoprosthesis using the upper
`access, which made it easier to insert and
`control the transportation system, particularly
`in cases with tortuous iliac arteries.
`It also
`allowed delivery of the endoprosthesis to the
`target position when it was located in the
`
`Figure 14 ^ (A) Aortogram of the abdominal aorta before a procedure to implant a unibody bifurcated
`endoprosthesis (December 6, 1989).
`(B) Schematic drawing of
`the abdominal aortic procedure.
`(C)
`Intraprocedural aortogram showing twisting of the contralateral limb of the endoprosthesis.
`
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`J ENDOVASC THER
`2013;20(Suppl);I-3–I-23
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`DEVELOPMENT OF EVAR IN THE UKRAINE
`Volodos
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`I-13
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`Figure 15 ^ (A) Preoperative thoracic aortogram showing large anastomotic pseudoaneurysms at a previous
`coarctation repair. (B) Schematic drawing of the planned hybrid procedure. (C) Follow-up CT of thoracic aorta
`16 years after the hybrid procedure.
`
`Surgery Congress in 1992,22 Utrecht in 1994,26
`New York in 1994,29 and in Portland, Oregon,
`in 1995.33
`On May 12, 1993, we became the first to
`successfully place a unibody bifurcated endo-
`prosthesis inside a previously existing surgi-
`cally placed graft. The patient had a classical
`open aortobifemoral graft placed in 1984; 9
`years later, large diameter false aneurysms
`had developed in all 3 anastomoses. At
`operation, both distal anastomotic aneurysms
`
`were resected, and access was gained
`through the distal ends of both limbs of the
`existing graft (Fig. 19A). The left limb was
`used for placement of a catheter to which a
`ligature was attached. The suture was brought
`
`Figure 16 ^ Delivery system for hybrid thoracic
`procedure from axillary and femoral artery access-
`es.
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`DEVELOPMENT OF EVAR IN THE UKRAINE
`Volodos
`
`J ENDOVASC THER
`2013;20(Suppl):I-3–I-23
`
`Figure 17 ^ (A) Preoperative thoracic angiogram of a patient with an aortobronchial fistula. (B) Schematic
`drawing of the thoracic stent-graft procedure (August 19, 1993) to treat the fistula. (C) Completion angiogram
`showing exclusion of the aortobronchial fistula after the procedure. (D) CT 18 years after aortobronchial
`fistula repair; the stent-graft is patent and its position is unchanged.
`
`across the bifurcation of the previously exist-
`ing graft using a snare (Fig. 19B). The unibody
`bifurcated endoprosthesis used in this case
`had a special inverted cone attached to the
`end of the left limb of the endoprosthesis (Fig.
`19C). The suture brought from the left to the
`right groin was attached to a suture connect-
`ed to the inverted cone of the left limb. The
`unibody bifurcated endoprosthesis was
`brought up from the right groin to the level
`of the thoracic aorta, and with the left limb’s
`inverted cone above the bifurcation of the
`existing surgical graft,
`the endoprosthesis
`
`was unsheathed and pulled down until the
`top sealing stent was just below the renal
`arteries. Both unstented limbs of the endo-
`prosthesis came out from each groin. The
`patient was followed for 3 years, with excel-
`lent function of the endoprosthesis. This case
`was presented at the International Congress
`on Endovascular Interventions in Arizona in
`1994.25
`This unconventional way of placing a uni-
`body bifurcated stent-graft in a pre-existing
`surgical graft was based on experience
`gained from our analysis of our first unsuc-
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`

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`J ENDOVASC THER
`2013;20(Suppl);I-3–I-23
`
`DEVELOPMENT OF EVAR IN THE UKRAINE
`Volodos
`
`I-15
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`Figure 18 ^ (A) Schematic drawing of endoprosthetics of the abdominal aorta via 2 accesses using a tubular
`endoprosthesis. (B) Abdominal aortogram of a 66-year-old patient before insertion of a tubular stent-graft in
`the abdominal aorta via 2 access routes. (C) Completion aortogram; arrows show the extent of the stent-graft.
`
`cessful attempt in 1989. We learned that in
`order to avoid twisting of the contralateral
`limb, we had to position it above the bifurca-
`tion of the existing surgical graft, with the
`inverted cone attached to the ligature from the
`
`contralateral side, and then drag down the
`proximal stent across the thoracic aorta and
`abdominal branches. This was possible due to
`the discrepancy in the diameters of the larger
`thoracic aorta vs. the smaller infrarenal aorta.
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`DEVELOPMENT OF EVAR IN THE UKRAINE
`Volodos
`
`J ENDOVASC THER
`2013;20(Suppl):I-3–I-23
`
`Figure 19 ^ (A) Schematic drawing of a unibody aortic stent-graft to treat an infrarenal AAA. (B) The snare
`that transported the suture attached to the catheter across the bifurcation. (C) The cone on the end of the left
`limb of the bifurcated stent-graft and suture for attachment to the suture brought across the bifurcation to the
`right side.
`
`this operation
`The successful outcome of
`confirmed the feasibility of this method.
`In 1997, we developed another combined
`endovascular and open surgical approach for
`the treatment of AAAs, stenoses, and aorto-
`
`iliac occlusions through the pararectal ap-
`proach and left common iliac artery while
`using an inflated balloon catheter. The meth-
`od made it possible to reconstruct
`the
`bifurcation and both left and right common
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`

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`J ENDOVASC THER
`2013;20(Suppl);I-3–I-23
`
`DEVELOPMENT OF EVAR IN THE UKRAINE
`Volodos
`
`I-17
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`Figure 20 ^ (A) The pararectal access for a combined (hybrid) procedure on the aortoiliac segment. (B)
`Schematic drawing of the hybrid abdominal aortic stent-graft procedure using a unibody bifurcated device.
`
`iliac arteries; in addition, the inferior mesen-
`teric artery could be reimplanted to the
`endoprosthesis. We named it a ‘‘combined
`endovascular–surgical repair,’’ but now it is
`well known as a hybrid procedure. We used a
`specially designed bifurcated endoprosthesis
`in which the main body was fully stented,
`while the limbs were without stents. A small
`pararectal incision, typically on the left side,
`was made to gain access to the left common
`iliac artery (Fig. 20A) using a special set of
`retractors that were designed and construct-
`ed for this approach. Both common iliac
`arteries were then exposed. Using a delivery
`system specially developed for these proce-
`dures, the main body of the endoprosthesis
`was introduced from the left common iliac
`artery and placed in the infrarenal portion of
`the abdominal aorta under fluoroscopic con-
`trol (Fig. 20B). The distal end of the main
`body sealed the abdominal aorta at the level
`of the bifurcation. Special cuffs were used to
`achieve hemostasis in the exit area of the
`main body of the endoprosthesis. In cases of
`stenosis or occlusion of the more proximal
`abdominal aorta, endarterectomy of the aorta
`was performed with specially designed tools.
`Both limbs of
`the endoprosthesis were
`anastomosed to the distal end of the com-
`mon iliac arteries to ensure patency of the
`internal iliac arteries, which we considered to
`be of crucial importance. The inferior mes-
`enteric artery was reimplanted to the endo-
`prosthesis using a segment of autologous
`
`vein. Applying this method, we operated on
`11 patients with various pathologies of the
`abdominal aorta and the iliac arteries while
`using iterations of the same endoprostheses
`(Fig. 21).37,45,46,49,50,52,56,58 Seven of
`these
`patients were treated for AAAs, 2 for occlu-
`sion of the mid abdominal aorta, and 2 for
`stenosis of the abdominal aorta. All patients
`had severe pathology of the iliac arteries,
`including tortuosity, aneurysmal dilatation,
`and/or stenoses.
`In 1986, we began to use a hybrid
`approach especially designed for ruptured
`AAAs, which we called intraoperative endo-
`prosthetics. An endoprosthesis was intro-
`duced following laparotomy and deployed
`
`Figure 21 ^ Versions of the stent-grafts used for
`hybrid procedures from a paramedial access.
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`DEVELOPMENT OF EVAR IN THE UKRAINE
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`
`J ENDOVASC THER
`2013;20(Suppl):I-3–I-23
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`Figure 22 ^ (A) Schematic drawing of the shunts used in the intraoperative endoprosthetics procedure. (B)
`The instruments for the intraoperative endoprosthetics procedure in the abdominal aorta.
`
`below the renal arteries, achieving proximal
`anastomosis in a rapid fashion without
`aortic clamping. Temporary shunt