Medical Device Daily Associate Managing Editor
PARIS – The controversy began early here at the 2005 EuroPCR meeting being held at the Palais de Congr s.
In the opening symposium, the physicians on a panel covering the use of percutaneous coronary intervention (PCI) in challenging patients discussed how far they could take such technology, in essence challenging the already dwindling turf of the cardiac surgeon.
First up, and presenting a more conservative approach to the limits of PCI and the continuing merits of surgery, was William Wijns, co-director of the Cardiovascular Center at OLV Ziekenhuis (Aalst, Belgium).
Looking at bare-metal stents, he noted that based on a composite of studies comparing key endpoints – death, myocardial infarction, stroke and hospitalization – with use of those devices vs. coronary artery bypass surgery (CABG), “there is basically no difference between the two approaches in those patients who are deemed treatable by either one [cardiac interventionalist] or the other [cardiac surgery].”
The differences between the two approaches are only highlighted when the need for target vessel revascularization (TVR) is observed, Wijns said. In almost all cases, he said, it appears that the stent has the edge, with, perhaps, the notable exception of the diabetic patient.
Even with the notable improvements that have come with the drug-eluting stent (DES), he said that CABG is the benchmark by which most coronary interventional procedures should be measured.
“CABG provides durable results,” Wijns said, adding that it has “a well-defined and well-known safety profile,” one that he said PCI is still in the process of establishing, particularly in regard to the wildly successful, thus far, use of DES.
Painting a much more all-encompassing view of the value of PCI was Antonio Colombo, MD, of Centro Cuore Columbus (Milan, Italy).
Colombo, who has almost never met a vessel he couldn’t stent, outlined several areas that he said PCI can benefit in his presentation titled, “There are no limits: any anatomy, any patient.”
The primary problem he mentioned was that of chronic total occlusion (CTO). “Chronic total occlusion is a major limitation of angioplasty and a major limitation of stents, even drug-eluting stents,” he said.
That being said, Colombo discussed several CTO treatment options using DES, including one at his center in which six Cypher sirolimus-eluting stents were implanted in one patient, with no major adverse events evidenced after one year of follow-up.
He also described its use in patients with multi-vessel disease, including one clinical example from his center of triple-vessel disease in which an astounding total of nine Cypher DES were implanted.
“When you see a patient like this with multiple lesions on the left coronary and on the right coronary, you can convert these vessels into a well-functioning conduit,” Colombo said. However, he cautioned that one still has to be careful to protect the coronary branches. “You cannot just implant one stent after the other; it’s not like eating M&Ms.”
Colombo also mentioned the use of PCI in left main artery disease and in treating bifurcations.
Presenting the cardiac surgeons’ point of view was Gianni Angelini, MD, of Bristol Heart Institute at Bristol Royal Infirmary (Bristol, UK).
He noted that in the wake of DES, his profession may be down, but he joked that its members are certainly not an extinct species yet.
He said that much of the traditional surgeon’s territory that interventionalists are starting to move in to is very much pioneering work, and that surgeons are adapting new techniques of their own to try to preserve their turf, and perhaps expand it.
Emphasizing the fact that interventionalists are treading on new ground, he cited the example of Colombo. “I heard with interest the presentation of Dr. Colombo, who obviously is an extremely skilled individual but also very brave.”
Angelini noted that if, as Wijn stated in his address, surgery is “the ‘gold standard,’ I guess you will agree with me that PTCA [percutaneous transluminal coronary angioplasty] has got some limitations. You need to redo some more PTCA and you need occasionally [to do] surgical revascularization.”
He said the numbers thus far for DES trials have included only about 5% or 10% of the recruitable population. From the surgeons’ point of view, and quoting former British Prime Minister Margaret Thatcher, he noted: “Perhaps you’ve been a little bit economical with the truth.”
As a conservative estimate, he said that at least 60% of patients being treated every day by interventional cardiologists are receiving that treatment not based on solid clinical evidence or well-constructed randomized trials.
“What I think is happening here is that while we are all dealing with the same ‘apples,’ I think we are going to have to deal with the bad apples because you’ve taken the best already away from us,” Angelini said.
That isn’t to say that the surgeon isn’t to blame, he said, adding that cardiac surgeons are generally in a state of denial. “Denial means ‘What we are doing or what we have been doing for 40 years is great – why do we have to change?’”
The question the cardiac surgeon ultimately has to ask, said Angelini, is “What is the future leaving to us?” since the interventional cardiologist has become the “gatekeeper” to cardiovascular medicine.
With the “big key,” he said, one can do big things, such as open very difficult and worthwhile areas of medicine, or “we can have a different approach, which is evidence-based clinical medicine.”
Angelini said that he believes the cardiology field needs a referee, “who is going to provide our patients with information even before they have an angiogram.”
Ultimately, however, he said the next 10 years could see the demise not only of the cardiac surgeon but also PTCA, because of better pharmaceuticals and the rise of gene therapy, among other things. “Probably in 10 or 20 years, people will be laughing at what we do now, which will give me enough time to get to my retirement.”