Patient Safety Is the First Priority

We have read with great interest the paper by Hayashi et al¹ that was recently published in JACC: Case Reports. We are concerned that this case report contains a high survival bias and is inappropriate from both the humanitarian and the research ethical standpoints.

In the aforementioned paper, the investigators report that a superior vena cava injury, a rare but potentially fatal complication of lead extraction, was successfully treated with conservative follow-up. We agree that this case report has academic value. Furthermore, if special conditions (the patient’s history of coronary artery bypass graft surgery, which had caused adhesions of pleura or mediastinal tissue) are applicable and the vital signs are stable, conservative follow-up may be possible.¹

However, conservative follow-up should be only considered in an appropriate setting, after careful discussion with the relevant departments, such as cardiac surgery and anesthesiology. We do not recommend performing the procedure in the catheterization laboratory. Prompt intervention is difficult in the catheterization laboratory because of the inability to ensure sterility and the overwhelming vulnerability of equipment and manpower (ie, surgical equipment, cardiopulmonary bypass, anesthetic machine and equipment, well-trained scrub nurses, and medical engineers) if conversion to open heart surgery is required. Furthermore, if complications are rare but fatalities are high, the procedure should be planned with appropriate risk management and response measures in place (eg, it should be performed in a hybrid operating room; an on-site cardiac surgeon and a cardiac anesthesiologist should be available).

We understand that some patients may need to undergo lead extraction procedures. It is precisely for this reason that appropriate management must consider patient safety.2, 3, 4 It is unreasonable not to do so when risks can be avoided through appropriate management. In practice, serious accidents, including fatalities, have occurred in the catheterization laboratory when lead extraction has been performed, and these accidents should be fully considered when planning these procedures. Despite repeated warnings, the inclusion of such a rare survival case without considering cases that have resulted in serious accidents is arbitrary reporting with significant survival bias and may mislead the reader.