History of Peripheral Vascular InterventionsCHAPTER 1

The technique of angiography was first developed in 1927 by the Portuguese physician Egas Moniz (Fig. 1) at the University of Lisbon for viewing the brain vasculature (cerebral angiography).

Coronary catheterization was first performed when Werner Forssmann, in 1929, created an incision in one of his left antecubital veins and inserted a catheter into his venous system (Figs 2A to C). He then guided the catheter by fluoroscopy into his right atrium. Subsequently, he documented the procedure by having a chest roentgenogram performed.

Percutaneous transluminal angioplasty (PTA) for treating peripheral vascular disease was initially described by the US interventional radiologist Charles Theodore Dotter in 1964 (Fig. 3).¹ On January 16, 1964, Dotter percutaneously 5dilated a tight, localized stenosis 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 guidewire and coaxial Teflon catheters, the circulation returned to her leg.² The dilated artery stayed open until her death from pneumonia two and a half years later. Charles Dotter is commonly known as the “Father of Interventional Radiology” and was nominated for the Nobel Prize in medicine in 1978.

German cardiologist, Andreas Gruentzig (Fig. 4) revolutionized the technique in 1974 when he developed a soft, flexible, double-lumen balloon catheter for peripheral and coronary dilatations, as well as renal occlusive disease. He performed the first coronary angioplasty in September, 1977 (Figs 5A to C).³

Since the introduction of percutaneous transluminal coronary angioplasty (PTCA) by Gruentzig in 1977, major advancements have been made in the field of percutaneous vascular intervention. Puel (Fig. 6) and Sigwart (Fig. 7), in 1986, deployed the first intravascular stent to act as a scaffold, thus preventing vessel closure during angioplasty, and reducing the incidence of angiographic restenosis, which had an occurrence rate of 30–40%.⁴

Stent technology improved rapidly, and in 1989, the Palmaz-Schatz balloon-expandable stent was developed by Dr Julio Palmaz (Figs 8A and B). It focused on preventing late adverse events (such as stent restenosis and late thrombosis).⁵ Initial results with the Palmaz-Schatz stents were excellent when compared to balloon angioplasty, with a significantly lower incidence of abrupt closure and periprocedure complications. At approximately the same time, Cordis (a division of Johnson and Johnson) was developing the Cypher stent, a stent that would release sirolimus over time. The first study of individuals with these stents revealed a lack of restenosis (zero percent restenosis) at six months,⁶ and led to the approval for the stent to be used in Europe in April, 2002. About a year after approval in Europe, the United States FDA approved the use of the Cypher stent as the first drug-eluting stent for use in the general population in the United States.

In 1987, Theron et al published findings on internal carotid angioplasty in 48 patients with de novo atherosclerosis or postsurgical restenosis.⁸ Technical success was achieved in 94% of cases, with a 4.1% rate of serious morbidity. In Kachel's review of the literature through 1995, 523 carotid angioplasty procedures were reported.⁹ The overall technical success rate was 96.2%, with a 2.1% rate of morbidity, 6.3% rate of transient minor complications, and no deaths.

In 2001, the SAPPHIRE trial¹¹ (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) was started by FDA involving CAS with the simultaneous use of EPDs.

The aim of this trial was not to show that stenting is superior to surgery, but that it is not inferior by a difference of 3%. A total of 747 patients were enrolled in this trial. The study protocol randomized high-risk patients defined as:

Symptomatic patients with 50% luminal stenosis or asymptomatic patients with 80% luminal stenosis were accepted into this randomized trial. Cardiologists, radiologists, surgeons, and neurologists all participated in the decisions on which patients would be allowed into the trial. Actually, the nonrandomized stent arm (NRSA) of this trial was defined by the surgeons themselves. The EPD used in SAPPHIRE was the Angioguard, by Cordis. The study had 3 arms:

At 2 years, patients receiving CAS with EPD fared significantly better than those undergoing CEA in the composite endpoint of death, stroke, and myocardial infarction (12.0% vs 20.1%, P < 0.05). However, this result was driven primarily by myocardial infarction, because there was no significant difference in death or stroke (the trend still favored CAS). In symptomatic patients, no statistically significant difference existed between the CAS and the CEA groups (16.8% vs 16.5%). Again in asymptomatic patients, no difference existed between the CAS and the CEA groups (5.4 vs 10.2, P = 0.20).

The Acculink for Revascularization of Carotids in High-Risk Patients (ARCHeR) was a prospective trial with CAS and EPD using the RX AccuLink Carotid Stent System and the RX Accunet Embolic Protection System in high-risk surgical patients.¹² This study enrolled, in 3 single-arm trials, 581 patients who met the following criteria: 50% symptomatic stenosis or 80% asymptomatic stenosis with one of the following:

The primary endpoint of death, myocardial infarction, and stroke at up to 2 years in ARCHeR 1 and 2 were 8.3% and 10.2%, respectively. ARCHeR 1 used the Acculink nitinol stent without cerebral protection, whereas ARCHeR 2 used a cerebral protection device. ARCHeR 3 was similar in the usage of the stent and EPD; however, the monorail delivery system was used exclusively during this phase of the trial. Not enough patients in this trial have reached 1 year; therefore, the ARCHeR 3 results are unavailable.

10Currently, a large study, Carotid Revascularization: Endarterectomy vs Stenting Trial (CREST), has shown that CAS is better than CEA.

Carotid endarterectomy has been a mainstay in the treatment of carotid occlusive disease. Many critics have viewed carotid artery stenting as a niche procedure, which they feel will not withstand the pressures of multidiscipline physician and government involvement. Unfortunately, in the CEA trials, investigators have looked only at low-risk patients and have extrapolated the results to high-risk patients in clinical practice.

Others complain that there are no long-term data. Then, on the basis of recent trial data, it is fair to state that in high-risk patients, CAS is the procedure of choice. In the future, as endovascular therapy becomes further refined, with better EPDs, better stents (drug-eluting), and more experienced operators, mortality and morbidity rates associated with the procedure will continue to decline.

History is fickle. When surgeons pioneered carotid endarterectomy, they outpaced medical therapy. Surgical therapy was a moving target, and medical therapy could not keep up. Times are again changing. Endovascular therapy—with its innovations—is now the moving target, while surgical therapy has had minor changes. Just as medical therapy has a role in mild-to-moderate lesions, endovascular therapy has a role in this huge population, but its exact nature remains to be seen.

The iliac arteries are technically among the easiest vessels to approach percutaneously and are the largest peripheral lower extremity vessels with the highest flow rates. These factors optimize the outcome of percutaneous transluminal angioplasty (PTA) and stenting.

Aortic bifurcation reconstruction, once the sole realm of surgical bypass, is now performed successfully using percutaneous techniques.

The role of infrainguinal angioplasty and stenting in the treatment of lower-extremity ischemia is more controversial than PTA and stenting for aortoiliac occlusive disease. Although percutaneous revascularization plays a less prominent role in the infrainguinal vasculature than in the aortoiliac system, it remains attractive as a minimally invasive alternative to surgical bypass, requiring shorter hospital stays and permitting faster recovery. Although dilatation of the common femoral and profunda femoral arteries is sometimes indicated, the most commonly treated femoropopliteal vessels are the superficial femoral artery (SFA) and popliteal artery.

On September 7, 1990, Dr Juan C Parodi and his team at the Instituto Cardiovascular de Buenos Aires (ICBA, Buenos Aires, Argentina) treated the first endovascular abdominal aortic aneurysm (AAA) patient. The aneurysm was excluded endoluminally with a Dacron graft that was anchored at 13the proximal infrarenal neck with a stainless steel balloon-expandable stent. The system was assembled by affixing (with sutures) the fabric tube to an undeployed stent mounted on a large-diameter angioplasty balloon. The contraption was then sheathed inside a large-bore catheter that served as the delivery system. Access to the aorta for delivery and deployment was achieved in a retrograde transluminal fashion through the surgically exposed common femoral artery. It worked, resulting in exclusion and depressurization of the large aneurysm in a patient who had been deemed an unsuitable candidate for standard surgical repair. Much work, experimentation and design preceded the launch of the clinical program. And while the initial few patients in the series were treated using a similar approach, subsequent technical iterations and modifications became necessary as lessons were learned with rapidly mounting clinical experience.

Ukrainian surgeon Nicholas Volodos had performed endovascular repair of a traumatic-origin thoracic aortic aneurysm as early as 1986, which was, however, unknown to anyone at that time. It was Parodi's initial clinical experience with endovascular treatment of abdominal aortic aneurysms (AAA) that became the driving force and stimulus for growth in interest, creativity and investment that followed throughout the 1990s and beyond.