Should smart operators mix business and surgery

No one knows for sure exactly how the market for minimally invasive surgery will be divided up in 10 years’ time. Partly for this reason, the majority of heart surgeons are still cautiously watching from the sidelines, waiting to see results, assessing among other things how hard these new procedures are to do. But they will not be able to wait forever. There is too much at stake—for patients, surgeons, cardiologists, investors, and thirdparty payers. What is more, as you all know, widespread media coverage is already spurring patient demand for minimally invasive procedures. Under this kind of pressure, at least in the beginning, in some centers, minimally invasive operations will likely be done by some surgeons who are not adequately prepared to do them. Up to 1995, there had been no minimally invasive beating heart surgery done in the United States. By the end of 1998 there could be more than 300 medical centers in this country doing it on humans. Even if these numbers are inflated, there has been an explosion of activity and it is not unreasonable to assume that at some centers for some time morbidity will be too high. The availability of a variety of minimally invasive procedures (eg, Port-Access [Heartport, Redwood City, CA], Octopus [Medtronic, Minneapolis, MN], MIDCAB [CardioThoracic Systems, Cupertino, CA]) poses a dilemma for clinicians and patients who are candidates for minimally invasive surgery. To appropriately refer such patients, a diligent cardiologist has to do the following: read the limited literature on these procedures (there have been no head-to-head trials); factor in what is known about risks associated with the heart-lung machine and imperfectly sewn bypass grafts; consider the skill of the surgeons and the overall quality of the cardiac surgery programs at the institutions doing each procedure; try to share this rather vague, uncertain information with anxious and often ill-informed patients; add in an adequate account of the standard bypass procedure and, where appropriate, angioplasty and atherectomy options with their trade-offs; and finally, help the patient choose a treatment. If this is difficult for the cardiologist, imagine how hard it must be for these patients. Surgeons who do these procedures, some of whom have financial interests in the companies promoting them, are interested parties who have one or more incentives for wanting to influence the treatment choice patients make in consultation with their cardiologists. I know of a recent situation in which a patient who was advised at one hospital to have an open chest beating heart operation went to the chief of cardiology at a neighboring hospital and was advised to have a Heartport operation. Guess which hospital does which procedure. Eugene Braunwald did not have minimally invasive surgery in mind when he warned 20 years ago that “an industry is being built around” bypass surgery. Nor did he necessarily foresee Wall Street’s influence on the direction of bypass surgery. But today he looks prescient nonetheless. And his concern that bypass surgery would develop “a momentum and a constituency of its own” has proved accurate. Many others, surgeons among them, have expressed concern about the extent to which stock prices and market share are driving their profession. The commodification of a surgical procedure generates a variety of moral problems. For example, when two start-up companies with similar products compete for the same set of patients, the pressure to get to market first can easily lead to cutting corners and fudging data. If the company is publicly owned, the rationale for the cutting and fudging is usually a duty to shareholders: Being second can have disastrous financial consequences. Treating an operation as a product and health care as a business opportunity also sets up conflicts of interest for surgeons who will benefit financially if one procedure wins greater market share than another. Two of the first companies in the market, Heartport and CardioThoracic Systems (CTS) are based in California. Both develop and sell minimally invasive cardiac surgery products. Heartport’s system was first tested at Stanford, and CTS’s beating heart surgery was first done in Argentina. For the purposes of this article, let us view the two procedures in a hypothetical situation using made-up characters in a made-up metropolis called New Market. A competition of sorts is under way between Irving Gallagher at New Market University Hospital and Cal Cardigan at Spode Hill Hospital. The New Market University surgeon has done Heartport’s on-pump operation more than any other surgeon anywhere in the world. At Spode Hill, Cardigan has done more MIDCABs than anyone. Each surgeon is an apostle for the operation he does, and he owns stock in the company. Cardigan’s reputation is now linked inextricably, for better or for worse, to the success of off-pump surgery. It is also, for now at least, linked directly to the success of CTS. His 6-month patency rate was a relatively poor 86% before he began using the CTS kit, and a much better, but still not quite optimal, 93% after he began using it. Gallagher is as committed to Heartport and on-pump Presented at “Facts and Myths in Minimally Invasive Cardiac Surgery: Current Trends in Thoracic Surgery IV,” New Orleans, LA, Jan 24, 1998.