His to r ica 1 No te
`
`1992: Parodi, Montefiore, and the First
`Abdominal Aortic Aneurysm Stent Graft in
`the United States
`
`Frank J . Veith, MD, Michael L. Marin, MD, Jacob Cynarnon, MD, Claudio Schonholz, MD,
`and Juan Parodi, MD, N e w York, N e w York
`
`In 1990 Juan C. Parodi performed the first endovascular abdominal aortic aneurysm (AAA)
`repair in Buenos Aires. Two years later, in 1992, Parodi and Claudio Schonholz visited Mont-
`efiore Medical Center in New York to perform with us the first endovascular AAA repair to be
`done in the United States. Since then the Montefiore/Einstein vascular group has performed
`1522 endovascular grafts in 674 patients for many types of vascular lesions using a variety of
`both surgeon-made and industry-made devices. The purpose of the present article is to describe
`the events that surrounded the performance of the first seminal endovascular AAA repair at our
`institution on November 23, 1992.
`
`In 1990, Juan C. Parodi performed the first endo-
`vascular abdominal aortic aneurysm (AAA) repair
`in Buenos Aires.’ Two years later, Parodi and
`Claudio Schonholz visited Montefiore Medical
`Center in New York to perform with us the first
`endovascular AAA repair to be done in the United
`States.2 Since then, the MontefioreIEinstein vas-
`cular group has treated 674 patients with endo-
`vascular stented grafts for many types of vascular
`lesion using a variety of both surgeon-made and
`Our purpose here is to
`industry-made
`describe the events that surrounded the perfor-
`mance of the first seminal endovascular AAA repair
`at our institution on November 23, 1992.
`Interest in less invasive endovascular treatment
`for vascular lesions was long-standing at our insti-
`
`Division of Vascular Surgery, Department of Surgery, Montefiore
`Medical Center-Albert Einstein College of Medicine, New York, NY,
`USA.
`Correspondence to: Frank J . Veith, MD. Division of Vascular Sur-
`ge ry, Department of Surgery, Montefiore Medical Center-Albert Einstein
`College of Medicine, I 1 I East 210th Street, New York, N Y 10467, USA,
`E-mail: fivmd@msn.com
`Ann Vasc Surg 2005; 19: 749-751
`DOI: 10.1007/~10016-005-6858-9
`0 Annals of Vascular Surgery Inc.
`Published online: July 29, 2005
`
`tution. The vascular surgeons at Montefiore Med-
`ical Center had promoted aggressive treatment of
`patients to save threatened limbs. Many of these
`paticnts had complex multilevel vascular disease,
`along with serious cardiopulmonary comorbidities.
`In the mid- 1970s, the vascular surgery group with
`the collaboration of interventional radiologists had
`begun innovative efforts in the use of percutaneous
`transluminal angioplasty as a supplement to vari-
`ous bypasses in some of these patient^.^,^
`As a result of these interdisciplinary efforts with
`limb salvage patients, collaboration between the
`Divisions of Vascular Surgery and Interventional
`Radiology at our institution reached a high level.
`Accordingly, Dr. Frank Veith was frequently in-
`vited to participate in interventional radiology
`meetings and symposia. At Dr. Barry Katzen’s
`international meeting in Miami in January 1987,
`Dr. Julio Palmaz gave a talk about the potential of
`intravascular stents. In that talk, he indicated that
`Parodi and later he had conceptualized the use of
`stented grafts to treat AAAs. This talk made a pro-
`found impression that resulted in several sub-
`sequent discussions among members of
`the
`Montefiore vascular group (Frank Veith, Thomas
`Panetta, Jacob Cynamon, and Michael Marin)
`
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`TMT 2098
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`750 Veith et al.
`
`Annals of Vascular Surgery
`
`regarding the possibility of endovascular grafts as a
`less invasive treatment for a variety of vascular
`lesions. These discussions remained
`theoretical
`until the publication by Parodi, Palmaz, and Barone
`of their 1991 landmark paper describing the first
`several cases in which endovascular grafts were
`used to treat AAAs.’
`In August 1992, a 76-year-old man with severe
`oxygen-dependent pulmonary insufficiency, coro-
`nary artery disease, and recurrent ventricular
`tachyarrhythmia was found to have a 7.5 cm
`painful and tender infrarenal AAA. Dr. Marin was
`asked to see the patient, and he agreed with all of
`the medical consultants that the patient was too
`sick and too high a risk for any form of standard
`open surgical repair. Dr. Marin then called Dr.
`Veith to discuss other treatment options, including
`the possibility of an endovascular graft repair.
`It was agreed that both surgeons would travel to
`Buenos Aires to learn Dr. Parodi’s technique, with
`the goal of returning and performing an endovas-
`cular graft repair on their patient. Veith then called
`Parodi to discuss this possibility and invited him to
`present his work at the annual Montefiore/Einstein
`Vascular Surgery Symposium in New York the
`following November. Drs. Veith and Marin offered
`to journey to Buenos Aires to observe some cases.
`Dr. Parodi indicated that he had no imminent cases
`scheduled. However, he was to give a talk at a
`meeting of interventional cardiologists in Milwau-
`kee. He suggested that Drs. Veith and Marin meet
`him there to discuss the patient and how endo-
`vascular graft treatment might be accomplished. He
`asked that, in the meantime, computed tomo-
`graphic (CT) scans and angiograms be sent to him
`so that he could evaluate the patient’s suitability for
`an endovascular graft. These X-rays were sent but
`never received.
`Dr. Marin met Dr. Parodi in Milwaukee with
`another copy of the patient’s X-rays to review. It
`was agreed that the patient was a good candidate
`for an endovascular graft repair, but the logistics of
`accomplishing that repair were left undecided.
`These details were worked out in several long-
`distance telephone discussions. It was agreed that it
`would be best to treat the patient in New York and
`that this might best be accomplished around the
`time of the MontefiorelEinstein annual meeting to
`be held in November 1992. However, several con-
`ditions had to be fulfilled. The first was that
`Johnson 6 Johnson, who had acquired the rights to
`Parodi’s and Palmaz’s patents, would have to ap-
`prove the use of a large Palmaz stent in the United
`States since no Food and Drug Administration
`(FDA) Investigational Device Exemption yet ex-
`
`isted for that stent. Parodi also requested that Drs.
`Schonholz, a talented interventionalist with whom
`he worked, and Hector Barone, who was assem-
`bling various components of
`the endovascular
`grafting system, also be brought to New York to
`participate in the procedure. Funds to bring the
`three Argentinians to the United States and keep
`them here for the duration of the symposium and
`the surgical procedure were obtained from a grant
`from the James Hilton Manning and Emma Austin
`Manning Foundation.
`Dr. Veith then called Paul Marshall, Director of
`New Products at Johnson 6 Johnson Interventional
`Systems (JGJIS), the company that was developing
`the Palmaz stent, to obtain permission to use the
`large Palmaz stent (P 5014) to construct the graft to
`treat the patient. Marshall, a long-time friend of Dr.
`Veith, indicated that J€rJIS had serious concerns
`about allowing Drs. Parodi, Veith, and Marin to use
`the stent because they feared that it might jeopar-
`dize the FDA applications for the Palmaz-Schatz
`Coronary Stents that were currently well into the
`approval process. Marshall said he could not make
`a final decision to allow Parodi and his colleagues to
`use, in the United States, the JGJIS large stent or
`any similar large balloon-expandable stem that was
`manufactured in Argentina by Carlos Sommer.
`Veith then requested a meeting with Marvin
`Woodall, president of J&JIS, to see if he could be
`persuaded to allow the combined Argentinian-
`Montefiore group to proceed with the procedure
`based on compassionate considerations. A meeting
`between Marshall, Woodall, Veith, and Marin took
`place at a restaurant in the Marriott Hotel adjacent
`to Newark Airport. The J€JJIS officials were clearly
`reluctant to grant permission to proceed with the
`use of the large stent because of their legitimate
`concerns that such usage might jeopardize the
`imminent approval of their coronary stents. How-
`ever, after a 4 hr conversation and explicit
`descriptions of concerns for the patient’s welfare if
`he went untreated, the J€JJIS officials relented and
`agreed to permit Dr. Parodi to participate in the
`case, although they indicated that they could not
`supply the JGJIS stent. Dr. Barone and Mr. Dom-
`mer would have to provide one that was similar.
`After institutional review board approval and
`informed consent from the patient and his wife
`were obtained, the procedure was carried out un-
`der local anesthesia on November 23, 1992. Drs.
`Parodi and Schonholz, along with Drs. Marin, Ve-
`ith, and Cynamon, performed the procedure, in
`which a 22 mm DacronTM prosthesis, sewn to a
`large Palmaz-type stent, was inserted via a right
`femoral arteriotomy. Using digital fluoroscopic
`
`

`

`Vol. 19, No. 5, 2005
`
`1992: Parodi, Montefiore, and the first AAA stent graft 75 1
`
`guidance, the graft was positioned and fixed to the
`proximal nonaneurysmal aorta using a large bal-
`loon to expand the proximal stent. Aneurysm
`exclusion was demonstrated on intraprocedural
`arteriography, postprocedural CT scan examina-
`tion, and duplex ultrasonography. In addition, the
`prominent pulsation of
`the aneurysm was no
`longer present and his symptoms were relieved. He
`was discharged a few days later and remained
`symptom-free until he succumbed to his cardio-
`pulmonary comorbidities approximately 9 months
`after his procedure.
`This experience demonstrated to us the feasi-
`bility of endovascular aneurysm repair and estab-
`lished a collaborative relationship and a warm
`collegiality between the New York and Argentinian
`groups. Continued collaboration between these
`groups has resulted in numerous advances in the
`endovascular treatment of aneurysms and other
`vascular lesions.
`The practice of vascular surgery at Montefiore
`and many other centers and institutions was clearly
`influenced by this case, which increased awareness
`in the United States and elsewhere of Dr. Parodi’s
`landmark achievement. The impact of endovascu-
`lar treatments continues to influence the way
`vascular patients are treated. Indeed, this case
`
`helped to start a trend, the limits of which have yet
`to be defined.
`
`This work was supported by grants from the US. Public Health
`Service (HL 02990-03), the James Hilton Manning and Emma
`Austin Manning Foundation, the Anna S. Brown Trust, and
`the New York Institute for Vascular Studies.
`
`REFERENCES
`
`1.
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`2.
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`3.
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`4.
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`5.
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`Marin ML, Veith FJ, Cynamon J. Initial experience with
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