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Responsible Innovation in Cardiac Surgery

Sidney Levitsky
Sidney Levitsky

Sid Levitsky, the David W. and David Cheever Professor of Surgery at Harvard Medical School, began his Bigelow lecture by describing the recent transition in the common understanding of the role of physicians. In the distant past, doctors were recognized as altruistic and scholarly stewards of the canon of medicine. In recent years the role of the physician has been reinterpreted as similar to that of a production worker. The language of a market civilization comprised of providers and consumers associated with this reinterpretation is clearly problematical.

17% of the gross domestic product of the United States is consumed by healthcare, yet 49.9 million Americans go without health insurance. Automobile manufacturers in the United States spend more on health insurance for their workers than they do on the steel that is put into US cars. 30% of healthcare expenditures are consumed by administration and 30% by defensive and non evidence-based treatments. Though the wound infection rate is reduced by 50% when antibiotics are properly administered in the peri-operative period, there is only 23% compliance with this best practice.

43% of Medicare costs in the United States go to treatment of cardiovascular disease. Levitsky showed a picture of a balloon angioplasty from a publication in the New England Journal of Medicine, showing a shower of fragments from the disrupted coronary lesion - spreading down stream and causing “infarctlets”. “It is not CPK–washout, as cardiologists would have us believe, but myocardial necrosis.” Hannan, in 2005, showed evidence that the need for redo interventions when stenting is used to treat coronary lesions far exceeds the need for retreatment after coronary bypass (1). In the United States there are currently 26% (formerly 11%) of cardiac surgical units that perform fewer than 100 operations per year. Clearly these were started in order to cover the cardiologists who are inserting stents. Douglas reported on 565,504 cardiac catheterizations (2). Disease was found in 23-100% depending on the catheterization lab.

“Clinical behaviour is unaffected by guidelines”. For example, evidence based guidelines counsel against attempting to dilate occluded vessels. Nevertheless, this is routinely practiced. The STS database now includes 4.5 million patients. It is audited, covers 95% of hospitals performing open heart surgery and has gained transparency by reporting results in Consumer’s Reports. Whereas formerly 20% of surgeons participated in public reporting, now 50% participate. One group, the Virginia Cardiac Surgery Quality Initiative group, has saved hundreds of millions of dollars through the application of evidence.

The one year stroke rate in Transarterial Aortic Valve Insertion (TAVI) patients is 8.3 % versus 4.3% in patients treated with open aortic valve surgery. A study in Austria using MRI, showed that 90% of TAVI patients had brain lesions (resulting from fracture of calcified aortic valves in order to make a place for the new prosthesis). Who should do TAVI? It seems prudent to look at the STS database for hospitals doing 2 or more aortic valve replacements per week. The STS will recommend 150, not all 1100 cardiac surgical centers, to do TAVI. The recommendation includes training to improve the catheter and “wireskills” of surgeons, and to require that two surgeons evaluate each case.

Bill Bigelow
Bill Bigelow

Wilfred (Bill) Bigelow was a pioneer of cardiac surgery who introduced the use of hypothermia and electrical stimulation of the heart. He also introduced the pacemaker to Canadian surgery. His trainees populated the surgical programs throughout Canada, and his lasting contributions in clinical cardiac surgery, teaching, and research made him a legend. The Bigelow Lectureship was created to honour his memory and has brought distinguished surgeons and scientists to the University of Toronto for the past 5 years.

His overall theme was that evidence and transparency is the new paradigm for effective medical care. He noted that the problems with applying evidence based medicine will be more difficult in the United States, a society which evolved from a revolutionary culture, whereas Canada evolved from an imperial culture.

Marv Tile asked “Who drives the industrial dominance, for example, who advised Johnson & Johnson on their recent decisions to stop manufacturing stents and to buy an orthopedic device company?” Levitsky answered that there are lots of roles and influences in play including market and corporate values and “no sheriff funded to enforce guidelines”. There is a need for professionalism. We, the physicians, should advocate for patients and traditional values. John Bohnen asked: “Have advocacy groups a role?” The answer: “anecdotally - they appear before congressional committees and provide emotional testimony.” Tom Waddell asked: “When brilliant innovators like Michael Mack come up with new techniques, there is no evidence base of randomized trials or meta-analyses to support them.” Levitsky answered that we must make room for innovation and participate in its oversight. Levitsky served on the Lung Volume Reduction Surgery oversight committee for the National Institutes of health Trial of Emphysema Surgery. He has also served on Research Ethics Boards and emphasized the need for US to serve on such boards. He told us that Europe requires only safety to be demonstrated for innovations, whereas the United States requires safety and effectiveness. He ended the discussion by telling us “We need to innovate responsibly. Many IRBs inhibit innovation. I try to counter this on the IRB at Harvard.” He closed with Bigelow’s favourite quote, an aboriginal blessing: “May the Great Spirit hold you in the palm of his hand!”


1. Hannan, E., Racz, M.,Walford, G.,Jones, R., Thomas J. Ryan, T., Bennett. E., Culliford, A., Isom, W., Gold, J., Rose, E. Long-Term Outcomes of Coronary-Artery Bypass Grafting versus Stent Implantation. N Engl J Med 2005, 352:2174-2183

2. Douglas, P., Patel, M., Bailey, S., Dai D., Kaltenbach, L., Brindis, R., Messenger, J., Peterson, E. Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography. J Am Coll Cardiol, 2011; 58:801-809.

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