A journal is retracting a paper about a heart surgery technique after discovering the researchers did not have ethics approval to perform a the procedure on 130 patients. What’s more, the local cardiac surgical society had asked the first author to stop using the method in 2004, six years before the study was complete.
The patients in the study had atrial septal defects — a congenital hole in their hearts that allows blood to leak between chambers. The retraction note concludes with the editor in chief advising other surgeons to not use the method to close the hole described in the retracted article, “Long-term assay of off-pump atrial septal defect closure using vena caval inflow occlusion and minimally invasive approaches in 130 cases.”
A concern from a reader unraveled the paper. The retraction note explains how:
The online version of this article published on 17 October 2014 has been retracted at the request of the editor-in-chief and the President of Mashhad University of Medical Sciences following serious concerns regarding the validity of the methods used and the results reported, as expressed by a reader.
The authors were invited to clarify the situation and provide the raw data used for the analysis. However, since the raw data supplied were incomplete, an investigation was undertaken by the President of Mashhad University of Medical Sciences. The preliminary results of this investigation bring to light that:
1. The authors did not submit their study proposal to the University Ethics Committee and there is no record of their application for such approval.
2. In 2004, the first author was asked to abandon this method of surgery by the Iranian Society of Cardiac Surgery. According to the President of Mashhad University, the authors claim that “this study included the cases before 2004 and that they just followed the patients until 2010.” However, in the methods section of the article, it is stated that “Between 2002 and 2010, a total of 130 patients at Imam Reza Hospital (mean age 15 ± 12.71 years) underwent closure of secundum-type ASD, using direct suturing through right anterolateral minithoracotomy and ministernotomy without use of a cardiopulmonary bypass pump.”
These findings have prompted the editor-in-chief to retract the online version of this publication and to recommend that readers neither perform this surgery nor cite this article.
The first author on the paper is Mohammad Hassan Nezafati, who is a cardiac surgeon at Mashhad University of Medical Sciences, according to his LinkedIn profile. We’ve reached out to him, and to corresponding author Pouya Nezafati, also at Mashhad.
We’ve also contacted the president of the university, and the EIC of the journal for more information, as well as the Iranian Society of Cardiac Surgeons to see why they asked Nezafati to stop using his method.
Hat tip: Rolf Degen
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So the authors claimed to have encountered 130 people with this congenital heart defect over a 24-month period. Five a month, or about one operation a week. Well, this is a very common defect, so that does seem possible.
Wow, this sounds … dangerous. All retractions have real implications, but this paper might have more potential for harm than most others.
It would be very interesting to know the outcomes of the 130 procedures. Did a high percentage of patients die on the table? Were there post-op complications? What was the post-op mortality?
Without ethics clearance, any findings are toxic, yes? This research never happened, as far as legitimate science is concerned. That is how you protect research participants.
Surgeons will routinely “tweak” their technical approaches without IRB approval, so long as they fully explain what they are doing to patients. This manuscript stated, though: “Informed consent was obtained from all patients. All procedures were approved by the ethics committee of Mashhad University of Medical Sciences. Ethical issue: The study was conducted in accordance with the principles of the Declaration of Helsinki (1996 version) and Good Practice standards. All subjects signed informed consent forms.” But the ethics committee apparently was never consulted.
If you examine the technique itself, it does seem rather dangerous. The heart is still beating, the venae cavae are now occluded, and the right atrium is open. Where does the blood in the left ventricle and left atrium go? If the heart empties at all (which I am guessing it must), then air is introduced into the left heart, which would be disastrous. Doing all the authors claim to do in 50-80 seconds seems unlikely, as well. (Note: I am a pediatric cardiologist and am routinely in the operating suite, although I do not perform surgery myself. I will need to run this by our cardiac surgeon!)
The authors reported zero mortality, and no neurological or behavioral consequences.
Follow-up with those contacted by Retraction Watch will be very informative indeed.