We all are goaded to believe that sensitisation towards ethical behaviour in ‘Medicine’ has taken a pole position. Just because the Committee on Publication Ethics (COPE) mandates that every publication in a scientific journal must be accompanied with a ‘conflict of interest’ declaration, we take ethics in scientific endeavours as a ‘given’. No doubt, the declaration is being complied with, at least in ‘letters’; however, it would behove the medical profession to introspect — Are we really sticking to the underlying ethics in ‘spirit’? Isn’t conflict of interest creeping into every aspect of ‘Medicine’ surreptitiously? Let me illustrate this with 2 classical examples, how science can be manipulated covertly, without infringing on ethics overtly.

The first case in point is the recent Valve Academic Research Consortium (VARC) definition of end-points for aortic valve bioprostheses research. Valve thrombosis definition, as per VARC 2 guidelines, has been revised in the VARC 3 guidelines to include clinical significance and follow-up events [1]. We all know that in the PARTNER 3 trial (Placement of Aortic Transcatheter Valve Trial 3), according to VARC 2 definition, the incidence of valve thrombosis at 2 years in Transcatheter Aortic Valve Implantation (TAVI) was significantly more at 2.6%, as compared to 0.7% with Surgical Aortic Valve Replacement (SAVR) (p-0.02) [2]. However, if one were to use the VARC 3 definition, it would be clearly favouring TAVI, with virtually zero valve thrombosis incidence.

Even if we were to gulp this, gumption demands that the same tone and tenor should have been maintained for other end-points like peri-procedural myocardial infarction (MI). But in the VARC 3 definition [1], only enzymatic rise has been used for the definition of peri-procedural MI and the clinical import and the sequelae have not been included, thereby biasing the entire analysis against SAVR and favouring TAVI. Can there be anything more blatant than this? These and many more anomalies have been resented and represented against by American Association of Thoracic Surgery (AATS), Society of Thoracic Surgeons (STS), European Association of Cardiothoracic Surgery (EACTS), and the Asian and Latin-American Associations of Cardiovascular and Thoracic Surgery in a joint publication [3].

The second instance which elucidates my view, and raises a red herring, concerns once again the definition and import of peri-procedural MIs, but on a different platform of Coronary Artery Bypass Grafting (CABG) Versus Percutaneous Coronary Intervention (PCI) debate. The main difference between CABG and PCI is that CABG is associated with a higher incidence of peri-procedural MI, but lower follow-up spontaneous MI, while it is the reverse with PCI. We all know that myocardial injury is ubiquitous to all cardiac surgeries performed on cardiopulmonary bypass with aortic cross clamp, due to myocardial ischaemia. But not all myocardial injuries are clinically significant and surgeons have been crying hoarse that peri-procedural MIs are not prognostically significant and are not as sinister as spontaneous MIs. Therefore, even intuition bears testimony, as does hard data, that the long-term clinical outcomes of CABG are much better than PCI. However, the issue has been addressed from a very narrow and parochial vision. Just enzymatic rise, and that too to arbitrarily defined, relatively low levels, has been used to characterise peri-operative MI [4]. This has been used in most studies as a primary end-point, when comparing CABG with PCI. Obviously this biases all analyses to higher early major adverse clinical event (MACE) rates with CABG.

The surgeons’ view point in the matter has now been vindicated by a recent publication in New England Journal of Medicine (NEJM) [5]. Devereaux et al. looked at a cohort of 13,862 patients undergoing cardiac surgery prospectively. They measured high-sensitivity cardiac troponin I (hsCTnI) at 3–12 hours, 24 hours, 48 hours, and 72 hours after surgery. They had a 30-day mortality of 2.1%, and when they correlated the hsCTnI levels measured within one day after surgery to the mortality, they found that for CABG and aortic valve replacement (AVR), hsCTnI more than 5670 ngm/litre correlated with increased 30-day mortality. For other cardiac surgeries, this level was more than two times higher at 12,981 ngm/litre [5]. This flies in the face of the 4th Universal Definition of Myocardial Infarction (UDMI), which suggested that a concentration of more than 10 times the upper reference limit (URL) of cardiac troponin I should be used in the diagnosis of MI [4]. However, Devereaux et al. found that levels up to 218 times the URL for CABG and AVR and 499 times the URL for other cardiac surgeries, are not associated with increased mortality. Therefore using low levels of enzymatic rise in the 4th UDMI definition of peri-procedural MIs in studies comparing CABG & PCI is blatantly unfair to CABG.

No wonder, James de Lemos and Michael Jessen from University of Texas Southwestern Medical Centre, Dallas, wrote in an accompanying editorial, ‘….. currently recommended high-sensitivity cardiac troponin I thresholds for diagnosing perioperative myocardial infarction and significant myocardial injury are too low’ and ‘…..correlate poorly with clinically evident complications’ [6]. The levels of enzymatic rise need to be much higher than those recommended by current guidelines, as moderate elevations of troponin levels do not correlate well with clinical outcomes and hard end-points and are therefore not significant. Moreover, to make it clinically and prognostically meaningful, the definition of peri-procedural MI, besides raising the bar of enzymatic levels, should also include clinical outcomes.

And lastly, though we have been representing time and again that the surgeons are not given adequate representation in any guideline writing committee, the same trend continues uncorrected. Equitable representation was not given to the surgeons even in the VARC guidelines, wherein of the 23 member writing committee, there were only two surgeons, against 21 cardiologists. We have been bemoaning in futility for the last 3 decades hoping for a fair deal, convinced that the cardiologists and cardiac surgeons are the two sides of the same coin — co-dependant and inseparable. However, these remain ‘Platonic’ pleadings. In real world, Shakespearean ‘to each his own’ is as relevant today, as it was to Ursis in the play Macbeth. To expect that the cardiologists would be fair to the surgeons is quite akin to expecting that a tiger will not eat his victim just because the victim pleaded to be a vegetarian! It is time opportune that the cardiac surgeons take time off their busy operating schedules and spend some quality moments in academics, run their own randomised controlled trials (RCTs), and conduct propensity score matched analyses and other high-impact studies that can inform practice of ‘Medicine’. An overwhelming majority of the physicians and surgeons want to practice ethical and chaste medicine but are led into an inappropriate behaviour either due to academic pressure, or more often by misinformation through industry sponsored publications. We, the cardiothoracic surgical fraternity, therefore need to generate our own practice influencing data and guidelines, and then effectively disseminate them to the practicing clinicians — not only surgeons, but also to cardiologists and family physicians, who still are our referring base.

Sadly, as it stands today, medical ethics and conflicts of interest remain only rhetorical, to be professed in words, but not always brought to action.