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New Kid on the Block? – Part Two

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New Kid on the Block? – Part Two

New Kid on the Block? – Part Two

November 17, 2005

Part Two

By Jean Johnson for Veins1

Ask any European where Americans stand on the conservative-liberal spectrum and the answer will be a resounding: ultra–right!

Indeed, biology professor in The Netherlands, Marcel Dicke, Ph.D., said, “We find the differences you Americans think you have between Democrats and Republicans amusing at best. Both parties are way to the right compared to us here in Europe. Even the so-called progressive Americans pale when you compare not only their political and economic persuasions, but also their cultural and social ideologies. So it doesn’t surprise me that it was the Europeans that ran with the interventional radiology technology while the Americans muddled about and backwardly insisted it would never replace surgery.”

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A Recent History of IR Technology

  • 1973: Society of Interventional Radiology is organized

  • 1975: Andreas Gruentzig developed a catheter system with two openings onto which a polyvinylchloride balloon could be fitted.

  • 1977: Andreas Gruentzig performed the first coronary angioplasty on a human being in Zurich, Switzerland.

  • 1980's: Interventional radiologists were using catheters to stop a range of bleeding problems from those associated with major surgery to excessive bleeding from trauma and childbirth.

  • 1996: First uterine fibroid embolization (UFE) procedures introduced in the United States.

  • 2002: 15,000 to 20,000 UFE procedures had been performed world-wide, about half of them done in the United States.

  • The concept of remodeling the artery, or transluminal angioplasty, may have been introduced to the world by Portland, Oregon’s Charles Dotter, M.D. in 1964. But as Dicke notes, philosophical resistance within the American surgical community, as well as difficulties replicating Dotter’s success and complications arising from early angioplasties, resulted in this type of minimally-invasive medicine being rejected and ignored in the United States for nearly 15 years.

    It wasn’t Dicke’s fellow Hollanders that picked up on the stunning breakthrough since dubbed interventional radiology or IR. Instead, it was the Germans. Eberhart Zeitler. M.D. first studied the technique and then introduced colleague Andreas Gruentzig to Dotter’s pioneering method of opening up blocked arteries. Gruentzig was fated to meet his death in an airplane crash in 1985 at age 46, but prior to that, the brilliant German physician took Dotter’s angioplasty and ran with it.

    Beginning in his own kitchen, Gruentzig experimented with materials suitable for balloons that could be used to open arteries in the heart instead of progressively larger catheters Dotter had used on the leg. By 1975, the German had developed a catheter system with two openings onto which a polyvinylchloride balloon could be fitted. His work set in motion a revolution in medicine, and after he performed the first coronary angioplasty on a human being in Zurich, Switzerland in 1977, he presented his findings and received a standing ovation at the annual meeting of the American Heart Association – an organization that only the year before received another of Gruentzig’s papers with widespread skepticism.

    Throughout the 1980s, improvements in angioplasty grew exponentially as interventional cardiologists in the United States and elsewhere embraced the technology and explored its possibilities. During this period and into the 1990s, a large number of new interventional devices were invented and perfected, with some like lasers proving less effective than hoped for and others like intravascular ultrasound and stents gaining approvable by the Federal Drug Administration. Indeed, as stents became commonplace, the field of interventional cardiology enjoyed continued success to the degree that by 2001, almost two million angioplasties were performed world-wide, with an estimated increase of 8 percent annually.

    Meanwhile, back in the realm of interventional radiology

    One way of finding out what was going on in the area of interventional radiology when the cardiologists were having their hey day is to look at the name changes that took place in the Society of Interventional Radiology -- a group first organized in 1973. Only a year later in 1974, the group changed its name to the Society of Cardiovascular Radiology, a label that stood until 1983. Then, in order to reflect developments that were taking place in the larger scope of the field, the group opted for the more inclusive Society of Cardiovascular and Interventional Radiology. Finally, in order to recognize that the heart is only one of many organs in the body that radiologists can treat using catheter-delivered techniques, in 2002, the body opted to return to its original nomenclature: the Society of Interventional Radiology (SIR).

    All this jostling and name changing reflected the ongoing work in regular IR. By the 1980s, interventional radiologists were using catheters to stop a range of bleeding problems from those associated with major surgery to excessive bleeding from trauma and childbirth. Indeed, embolization, or cutting off the supply of blood to a particular area via catheter-driven technology was first used as an adjunct to decrease blood loss during a myomectomy or traditional open surgery in which non-cancerous growths (fibroids) are removed from the uterus.

    What surprised teams of physicians was that after the IR embolization, many patients had such a spontaneous reduction of fibroids symptoms that they no longer needed to have the surgery or myomectomy. This led to the first uterine fibroid embolization (UFE) procedures introduced in the United States in 1996. As UFE was continually successful in cutting off blood supply to fibroids causing the tumors to shrink and providing women symptomatic relief from fibroids, UFE began to be relatively widely used by 1998 -- a brief span of only two years since its introduction.

    Still, without a sensational breakthrough that revolutionized medicine like Gruentzig’s coronary artery angioplasty and along with continual reluctance within the traditional surgery community to acknowledge the benefits of interventional radiology, work proceeded without much fanfare. Consequently, the general public was largely unaware of IR’s developments whether associated with the pioneering work in UFE, treatment of varicose veins, abdominal aortic aneurysms, liver disease or any number of other ways interventional radiologists were using their specialty.

    In spite of halting progress, by the year 2002, 15,000 to 20,000 UFE procedures had been performed world-wide, with at least half of those in the United States. Thus, in 2002 at the 27th Annual Scientific Meeting of the Society for Interventional Radiology, no less than 50 papers were presented on uterine fibroid embolization.

    Papers from researchers and clinicians were all over the canvas. They explored comparisons between the more invasive surgical alternatives of hysterectomy (in which the uterus is removed along with the fibroids) and myomectomy (fibroids are taken only and the uterus is saved) to the minimally invasive interventional radiology procedure. Results that discussed success rates, after-effects, long-term prospects, and cost comparisons were presented as well. Associate Professor of Radiology and Vice Chairman of the Department of Radiology at Georgetown University Medical Center, James Spies, M.D., said, “There is a real need for this kind of research. We can best serve our patients by telling them about success rates, after-effects, and long-term results for UFE, as well as how it compares to hysterectomy and myomectomy.”

    From 2002, it’s been all up hill. By 2003 the first large multi-center study in Canada showed that UFE was poised to lead interventional radiology out of its new kid on the block status.

    “This multi-center study involving eight Canadian Ontario university and community hospitals confirms that uterine fibroid embolization is a safe and effective treatment for fibroids,” said epidemiologist and primary author of the study known as the Ontario UFE Trial, Gaylene Pron, Ph.D. “The study showed that uterine fibroid embolization was effective for multiple fibroids, large fibroids, and for women with an enlarged uterus. Significant improvements in heavy menstrual bleeding occurred in most women, even those with large uteri and minimal initial volume reductions.”

    Once again, the Americans were not to be left behind even if they were a bit slow coming out of the gates. In 2004 a large multi-center comparative trial showed that UFE offers a much faster recovery and a lower adverse event rate compared to myomectomy. Presented at the 29th Annual SIR meeting, the study found that patients went back to work in 10 days versus 37 days for the myomectomy surgery and that they returned to normal activities in 15 days compared to 44 days for women who underwent a myomectomy.

    “This study is significant because it is the first trial to compare the two primary uterus-sparing treatments widely available to treat fibroids. The problem with myomectomy is that it’s a local treatment for a global problem. Most women have multiple fibroids, and usually they can’t all be removed with myomectomy surgery. Uterine fibroid embolization is a global solution, and it’s effective for multiple fibroids,” said John Lipman, M.D., interventional radiologist and lead investigator on the study. “Uterine fibroid embolization offers many advantages for patients. In addition to a much quicker recovery time, the procedural blood loss is negligible with UFE. Myomectomy surgery can entail significant blood loss and in about 2 to 3 percent of the cases, an emergency hysterectomy is required because of it. A woman who chooses myomectomy as a treatment because she doesn’t want to lose her uterus may wake up without one.”

    If Lipman sounds a bit promotional – even strident and frustrated – perhaps we can extend a tolerant nod his way on the basis of the history interventional radiologists have endured.

    First, all IR’s glory went to Gruentzig and the cardiac interventional folks. Then the traditional surgical community gave short shrift to the IR folks. Even still, although increased communication between Ob-Gyn physicians and interventional radiologists is proceeding apace, some women find they must turn to the Internet, not their Ob-Gyn, to find out what’s up with UFE.

    How history will treat UFE and interventional radiology in the future is a question that’s up for grabs of course. Still if we wandered the halls of the scientific meetings these days, we’d probably overhear more than one conversation with experts wondering if interventional radiology will someday displace the dominance surgery currently retains. Whether a radical and dramatic transformation in medical care of that dimension will occur or not is clearly anyone’s guess. Still, at the very least, this new field of medicine bears watching. What interventional radiology has accomplished in less than three decades is nothing less than stunning. Where it will go from here will most likely not only help women with fibroids, but patients suffering from a range of problems.

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