Tricuspid transcatheter edge-to-edge repair in patients with a transvalvular cardiac implantable electronic device lead: a systematic review and meta-analysis of 5,453 patients
This systematic review and meta-analysis of 5,453 patients demonstrates that the presence of a transvalvular cardiac implantable electronic device lead does not significantly compromise the procedural success, acute effectiveness, or safety of tricuspid transcatheter edge-to-edge repair, nor does it increase the risk of lead injury, indicating that such leads should not preclude patients from receiving the procedure.
Original paper licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). This is an AI-generated explanation of the paper below. It is not written or endorsed by the authors. For technical accuracy, refer to the original paper. Read full disclaimer
For decades, the heart's right side was often treated as a secondary concern, a passive pathway for blood returning from the body. When the valve on this side, known as the tricuspid valve, began to leak, doctors often waited, hoping the problem would not worsen, or they waited until the patient was too frail for major surgery. In recent years, however, a new approach has emerged that allows doctors to repair this leaking valve without opening the chest. Using a thin, flexible tube guided through a vein, they can clip the valve leaflets together from the inside, much like a tailor mending a tear from the inside out. This procedure has become a standard option for many patients, offering relief from the breathlessness and fatigue caused by the leak.
Yet, a specific group of patients has remained on the sidelines of this progress. These are individuals who have a cardiac implantable electronic device, such as a pacemaker or a defibrillator, with a wire that passes directly through the tricuspid valve to reach the heart muscle. For years, the medical community has worried that this wire would get in the way of the repair. Doctors feared the wire might block the tool from grabbing the valve, or worse, that the repair device might accidentally catch the wire, damaging it and leaving the patient without their life-saving rhythm control. Because of these fears, many patients with these wires were simply told the new repair was too risky, even though they were the very people suffering from the valve leak that the wire helped cause.
A comprehensive new review of medical data has now put these long-held fears to the test. Researchers gathered information from nine different studies involving more than 5,400 patients who underwent this valve repair. They specifically looked at the outcomes for the roughly 1,400 patients who had a wire passing through the valve, comparing them directly to the thousands of patients who did not. The goal was to determine if the presence of the wire actually changed the success of the operation or the safety of the patient.
The findings are remarkably clear. The data shows that having a wire passing through the valve does not make the procedure harder or less successful. The doctors were just as likely to complete the repair successfully in patients with wires as in those without. The amount of blood leaking after the procedure was reduced to the same degree in both groups, and the patients felt just as much improvement in their daily lives. The review found no difference in the risk of complications during the hospital stay, such as bleeding or stroke, between the two groups. In fact, the consistency of the results was so strong across different hospitals and different years of practice that the researchers could say with high confidence that the wire does not hinder the repair.
Perhaps the most reassuring discovery concerns the wire itself. The primary fear was that the repair tool might snag the wire, causing it to break, disconnect, or become stuck. The researchers examined this specific risk across more than 1,300 patients who had wires. In every single one of these cases, the wire remained intact and fully functional. There were zero instances of the wire being damaged, dislodged, or requiring a new surgery to fix it because of the valve repair. This suggests that the fear of damaging the wire is largely theoretical and does not reflect what actually happens in the operating room.
While the procedure itself proved to be safe and effective for patients with wires, the study did note a subtle difference in how these patients fared in the long run. Patients with wires were slightly more likely to be hospitalized for heart failure or to pass away in the months following the procedure compared to those without wires. However, the researchers explain that this is almost certainly not because the valve repair caused harm. Instead, it reflects the underlying health of the patients. People who need a pacemaker or defibrillator wire often have more severe heart disease, more irregular heart rhythms, and a history of other heart surgeries than those who do not. The wire is a marker of a sicker heart, not a cause of the poor outcome. The valve repair itself performed just as well for them as it did for anyone else.
This research changes the conversation for doctors and patients alike. It suggests that the presence of a wire should no longer be an automatic reason to deny a patient a valve repair. Instead of a blanket rule that says "no wires allowed," the focus should shift to the specific anatomy of each patient. Doctors can now look at where the wire sits and whether it is touching the valve leaflets, rather than assuming the wire makes the procedure impossible. For the vast majority of patients, the wire is simply a bystander that does not interfere with the repair. The study confirms that the new, less invasive way to fix the leaking valve is a viable and safe option for the large number of people living with pacemakers and defibrillators, offering them a chance at a better quality of life without the need for open-heart surgery.
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