Key result
Congenital cardiac surgery outcomes in India cannot be directly compared to Western databases due to publication bias, late presentation, and complex comorbidities not captured by standard risk scores.
Comparing congenital heart surgery outcomes between India and Western countries is confounded by significant differences in patient presentation, comorbidities, and healthcare infrastructure.
The systematic review by Kadiyani et al.[1] compares surgical results of congenital heart disease (CHD) operated in Indian centers collected from publications with the outcomes of the Society of Thoracic Surgeons (STS) and European databases. The survey is the only publication to date to compare Indian outcomes of surgery for CHD with those in the West. The results of the survey only confirm what we always knew-now we have numbers to support the impression. In fact, given that this is a collation of Indian published results from isolated series, the bias inherent in extrapolating nationwide results from isolated published (mostly) single-center studies is inseparable: the natural tendency of units to showcase mainly good outcomes, the tendency of journals to not publish results of common lesions (editor/reviewer discretion) even if the results are good (what is new?, no addition to existing knowledge, not priority), or to reject less than average outcomes (reason: results not up to standard). Thus, it can be safely assumed that there would be worse outcomes in many centers than those published and also better ones that never appear as publications, the phenomenon that passes as “publication bias.” Comparison of published studies by individual centers to a database, therefore, is not reflective of the true state of affairs. Regrettably, most of us surgeons operating in India still do not contribute to a functioning Indian congenital heart surgical database. Hence, for now, we must live with the above handicap. The reasons for higher mortality in the Indian series than in the Western databases, as pointed out in the Discussion session of the article,[1] are not far to seek. Suboptimal conditions such as lack of adequate centers for diagnosis and treatment in vast tracts of our country lead to late referral and, therefore, late presentation.[2] Coupled with poor economic conditions in many affected families, treatment may get delayed even though diagnosis has been reached. Poor/nonexistent facilities for the safe transport of critically ill babies often lead to babies arriving at the treating surgeon in suboptimal condition. In government/charity-run institutions where surgery is economically feasible, long waiting lists due to limited beds and resources cause delays. In addition, not all operational units would be equally adept at all procedures. Instances of a diagnosis being reached only when a serious pulmonary infection forces the family to seek medical attention are common. Many of these may require mechanical ventilatory support. Many patients who need ventilatory support for pneumonia with an underlying shunt lesion causing pulmonary overflow and pulmonary hypertension will not extubate successfully till the heart defect is fixed. This situation is virtually nonexistent in Western countries, where diagnosis is reached before complications occur. In economically advanced countries, the anatomy is all that needs to be fixed. In a country like ours, anatomy and multiorgan pathology often need to be tackled. The other issue in our country is rampant antibiotic resistance. Newborn babies referred from another hospital are likely to harbor incipient nonobvious infections with resistant organisms that often manifest only postoperatively. Multiantibiotic resistance in community-acquired infections is a situation we all face in our patients. Even a patient operated in a pristine state will often become culture positive if he happens to be on a ventilator for more than a few days. The infections in our milieu are by Gram-negative bacteria 99% of the time, and it is, therefore, a matter of great worry to all involved if a particular patient (the younger the patient, the more the concern) does not get off intensive care unit (ICU) support quickly. It is never clear if the organism came with the patient or if the ICU gave it to him. And woe befalls if you leave a residual defect in a milieu that does not tolerate prolonged ICU stay. This situation is not to be seen in the West. ICU sepsis is rare there but very common here. The carbapenem and colistin groups of antibiotics are commonly on flow in our patients, while those in the West often get by only on ampicillin or a first-generation cephalosporin and gentamycin. The other common problem is the late presentation of CHD. Late presentation often leads to situations where a patient, while not clearly inoperable, is “borderline” operable. Here, the conclusion of operability versus inoperability is often retrospective, depending on the outcome after surgery. Not infrequently, we would operate to “give a patient a chance” based on the fact that he is still “young” with equivocal operability indicators. This situation usually does not occur in Western centers. And then, there is the nonuniform training system in all specialties with less emphasis on practical training, especially for surgeons. There is no national training program that makes a minimum number of independently performed procedures mandatory before going for the degree examination. There are now fellowships that help specialize. Often, however, the same operators or the same thinking running these fellowships do not allow the mandatory independent number of operations. Thus, it is up to the individual to have the insight to improve his skills by visiting other centers, watching others, and improving on specific shortcomings, or by accumulating sheer experience and improving based on that. All of the above lead to a situation where the final results are inferior to Western ones. However, in my own opinion, for a lesion-like transposition of great arteries with a 100% mortality, going by natural history, a surgeon with a 10% mortality, while perhaps not acceptable in many Western centers, is still doing a considerable service, when he has to tackle all the above situations in various combinations. A surgeon with a child with ventricular septal defect (VSD) that needs closure but with the child on a ventilator for pneumonia will need to operate when he gets that window of improving lung parameters and infection markers. Waiting in this situation is also fraught with the risk of recrudescence of infection. Would a 2% versus a 1% Western mortality be acceptable in this scenario? In my opinion, even 5% would be! In our country too, every surgeon has the option of operating on the ideal patient and refusing the nonideal. Refusal to operate on those with preexisting complications will result in superior outcomes, mimicking Western outcomes, leaving the nonideal ones alone (to be operated on by others). Or one might take a calculated chance and bite the bullet. When you do that, is it any surprise that you may get hit wicket or caught at the boundary or even clean-bowled sometimes? And that gives rise to imperfect outcomes. It is often connected to the philosophy of the surgeon – whether you want to showcase picture-perfect outcomes or help as many patients as possible, as long as operating in the situation can be supported by scientific and evidence-based logic. If pure surgery is to be considered, the difference in results in elective operations would generally be due to technical issues and preoperative conditions in complex lesions and patient selection despite preexisting comorbidity in the simpler operations. Nonelective procedures, therefore, carry a higher risk since they have more to do with preexistent conditions where there is pressure to operate early in a perceived window of opportunity. The Risk Stratification for Congenital Heart Surgery (RACHS) classification is mentioned in the paper.[1] Now, the RACHS-I groups the procedures by surgical complexity and technical difficulty. Comorbidities are not given weightage, except prematurity for patent ductus arteriosus (PDA) or age (for coarctation and total anomalous venous connections). It works when comparing results among equals (e.g., the STS with the European database). A VSD operated with pneumonia, on intermittent positive pressure ventilation (IPPR), may give outcomes as a RACHS 3 or 4 when it is technically just a VSD. Relying on such a classification that does not give weight to preexistent comorbidities that often coexist in our setup is, therefore, unsuitable for comparing our results to those from the West, and major modifications are needed. In my opinion, to avoid the above obfuscation of outcomes, the results of centers for each condition should be compared, with the denominator being not the total numbers being selected for surgery but the total number of patients coming to the center with that diagnosis. This would give true survival statistics for each diagnosis for each unit rather than being affected by selection bias. This is not to say that we do not strive to overcome the barriers that prevent us from achieving results equivalent to Western registries. To reproduce the results of our Western counterparts, we must mimic all the conditions operative there. Early (if not in utero) diagnosis, before the onset of complications, timely referral to a competent surgeon in a unit with all facilities (setting up an adequate number of units with adequate workforce), devoid of monetary impediments to quality care (insurance coverage or free government coverage),[3] where good ICU practices are enforced in an infection-free environment where antibiotics usage is scientific and trained workforce with good doctor–population and nurse–patient ratio is the norm. And to institute in our country systematic training programs of a uniform standard for all cardiac personnel, foremost among them surgeons, with sufficient practical exposure before they pass out of the training program so that they can hit the ground running as soon as they start independent practice. Many of the above are systemic and national policy changes like increased allocation to health on a national basis, improvement in socioeconomic status, education and hygiene levels, strict national policies to prevent indiscriminate antibiotic usage, financial assistance to families in need of interventions via insurance or health schemes, and uniform, standardized and monitored training protocols for cardiac personnel. It may be unfair to expect pediatric cardiac surgery results to improve sustainably and reproducibly from such a diverse milieu without improving all of the above and the overall standard of society.
No takes yet. Share an insight, caveat, or question.
Rajesh Sharma (2024) conducted an editorial in Congenital heart disease. Congenital cardiac surgery vs. Western databases (STS and European) was evaluated on Surgical outcomes and mortality. Congenital cardiac surgery outcomes in India cannot be directly compared to Western databases due to publication bias, late presentation, and complex comorbidities not captured by standard risk scores.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: