Specialist recognized 20 years later for first endovascular technique

Editor's note: Reprinted from the 39th annual Veithsymposium publication, Nov. 14-18, 2012, New York, NY. Schönholz is a professor at MUSC.

Vascular interventional radiologist Claudio Schönholz, M.D., Division of Interventional Radiology, Department of Radiology and Radiological Science, joined several colleagues in November 2012 to celebrate the anniversary of a revolution in vascular treatment performed 20 years ago.

Dr. Claudio Schönholz

The first endovascular treatment of an abdominal aortic aneurysm (EVAR) in North America was celebrated during the 39th annual VEITH symposium, a conference supporting vascular surgeons and other specialists recognizing new developments in clinical practice and research. The procedure was performed Nov. 23, 1992. Schönholz was joined by the procedure team of Juan Parodi, M.D., Frank J. Veith, M.D., Michael L. Marin, M.D., and Jacob Cynamon, M.D.

The story of how this technique was developed and adopted in the U.S. is a testament to the forward thinking and collaborative investigators who sought to expand the treatment options available to their patients.

Parodi originated the transformational surgical intervention when he performed the first EVAR two years earlier with Schönholz in Buenos Aires, Argentina. The Montefiore Medical Center in New York City was uniquely positioned to be the first U.S. site to embrace this new technology. Since the 1970s, the vascular surgery group there had been collaborating with interventional radiologists to develop percutaneous transluminal angioplasty as a supplement to the various open surgical bypass techniques routinely used to treat patients with life-and-limb-threatening vascular disease. As a result of this collaboration, Veith had become a routine participant in interventional radiology meetings. At a meeting in January 1987, he heard Julio Palmaz, inventor of the balloon expandable stent used in coronary arteries, give a talk about the potential of intravascular stents.

Clearly, Palmaz and Parodi had been thinking about the use of stents and stent-grafts to treat abdominal aortic aneurysms (AAA). Theoretical discussion translated relatively quickly to clinical reality, and by 1991, Parodi, Palmaz, and Hector Barone had published their landmark paper describing the first of several cases in which they successfully used EVAR.

These success stories galvanized the Montefiore group, and when a perfect candidate arose for the new technique, they acted. In August 1992, a 76-year-old man who had numerous comorbidities, including severe oxygen-dependent pulmonary insufficiency, presented to Marin with a 7.5-cm painful and tender renal AAA. The patient's comorbidities precluded the idea of open surgery, which would be risky. Marin consulted with Veith about other treatment options, including the possibility of taking advantage of the new endovascular technique. As detailed by the participants in an historical note in the Annals of Vascular Surgery in 2005, discussions ensued with Parodi. Marin and Veith even offered to visit Buenos Aires to observe the technique.

Because no such operations were scheduled, Parodi was invited to Montefiore. Before that happened, however, Parodi was able to meet with Marin at an interventional cardiology meeting in Milwaukee, where he evaluated the patient's X-rays and concluded that he was a good candidate for EVAR.

Arranging the surgery proved to be a complicated logistical matter. The procedure was planned to coincide with the 1992 Montefiore/Einstein meeting, Parodi planned to attend. But before this could take place, Johnson & Johnson, the company that held the Parodi and Palmaz patents, would have to approve the use of a large Palmaz stent in the U.S. The stent had not yet been approved by the U.S. Food and Drug Administration even for an Investigational Device Exemption.

Parodi also requested the participation of Schönholz, an interventional radiologist with whom he routinely worked, and Barone, who was involved in assembling the various components of the EVAR system.

A grant from the James Hilton Manning and Emma Austin Manning Foundation enabled the Argentinians to be brought to the United States for the duration of the symposium and the surgery. Johnson & Johnson was leery about allowing the procedure to be performed, for fear it would jeopardize approval by the Food and Drug Administration of the Palmaz-Schatz coronary stents that were then under review.

Persuaded by Veith and Marin on compassionate grounds that the operation should be done, however, the company agreed that Parodi could operate as long as he used his own stent setup rather than the one for Johnson & Johnson.
The long-awaited operation was performed on Nov. 23, 1992. The team used a 22-mm Dacron prosthesis sewn to a large Palmaz-type stent, which was inserted via a right femoral arteriotomy. Digital fluoroscopic guidance was used, and the stent was fixed to the proximal nonaneurysmal aorta using a balloon to expand the proximal stent.
Aneurysmal exclusion was demonstrated by a variety of imaging modalities, but more importantly, the prominent pulsation of the aneurysm was no longer present and the patient was able to be discharged a few days later with his symptoms relieved. He survived symptom-free for nine months, and ultimately succumbed to cardiopulmonary comorbidities.

Friday, Feb. 1, 2013