Managing Heart Rhythm and Implantable Device Considerations in Patients Undergoing Percutaneous Transcatheter Tricuspid Valve Replacement

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EP LAB DIGEST. 2025;25(6):6.

Bradley P Knight, MD, FACC, FHRS
Editor-in-Chief, EP Lab Digest

Dear Readers,

It was once taboo to entrap a transvenous pacemaker or defibrillator lead in the heart or vasculature. For patients with central venous stenosis who underwent venoplasty, the use of a stent to maintain patency was tempting but was never considered as an option given that the lead would never be able to be removed in the future. When surgeons would perform tricuspid valve surgery in patients with a transvenous right ventricular (RV) lead, they would often use techniques that would prevent the lead from being trapped under the valve ring. However, there are now percutaneous transcatheter tricuspid valve replacement (TTVR) options. The United States Food and Drug Administration recently approved the EVOQUE Tricuspid Valve Replacement System (Edwards Lifesciences) for patients with severe tricuspid regurgitation. A very high percentage of these patients already have a cardiac implantable electronic device (CIED) with a transvenous lead in place across the tricuspid valve, or do not have a device and develop heart block after the procedure. This procedure has suddenly forced collaboration between interventionalists and electrophysiologists. 

Commercial availability of the EVOQUE TTVR device was based on the results of the TRISCEND II pivotal trial period.¹ This trial enrolled 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either TTVR or medical therapy alone. About one-third had a preexisting CIED. The composite primary outcome was death from any cause, implantation of an RV assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least 1 New York Heart Association functional class, and an improvement of at least 30 meters on the 6-minute walk distance. At 1 year, the win ratio for the composite endpoint favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). A new permanent pacemaker was implanted in 17.4% of patients undergoing TTVR. 

As with the advent of transcatheter aortic valve replacement, which can also result in heart block, there are many new questions related to the TTVR procedure pertinent to electrophysiologists. This includes:

•     What are the preimplantation predictors of heart block?
•     What strategies are available to minimize heart block during the procedure?
•     Could new devices be developed to avoid focal pressure on the conduction system along the septal aspect of the tricuspid valve?
•     Which patients with preexisting transvalvular leads should have their lead extracted prior to TTVR? 
•     How can dislodgement or injury to the transvenous lead during TTVR be avoided?
•     What are the long-term outcomes of patients with entrapped (“jailed”) leads?
•     How to best manage patients with procedure-related heart block while avoiding placement of a lead across the tricuspid valve, which would include placement of a leadless pacemaker system or placement of a coronary sinus lead?

Other considerations are that there are limited options for patients who are pacemaker dependent post TTVR and who need a defibrillator, and if some patients with severe TR and a CIED might be best treated with transcatheter edge-to-edge repair (TEER).

Peigh et al addressed the issue of what happens to patients with entrapped CIED leads after TTVR at Heart Rhythm 2025.² They looked at the outcomes of 108 patients who underwent TTVR with the EVOQUE device. Of those patients, 43 had a preexisting transvenous RV lead that was entrapped during TTVR. Of those patients, 14.6% were pacemaker dependent. Only 3 patients had a lead-related complication. One patient had intraprocedural dislodgement of the RV lead managed with implantation of a coronary sinus lead; this complication occurred during the early feasibility trial with the device, and techniques have been developed to avoid this problem. A second patient had an ICD lead fracture 2 months after TTVR causing inappropriate shocks; the implantable cardioverter-defibrillator (ICD) was deactivated, and because there was no longer a class I indication for a defibrillator, a leadless pacemaker was implanted. A third patient developed bacteremia and sepsis 1 month after the procedure and died. In the remaining 39 patients, there was a statistically significant increase in the RV threshold, a decrease in the R-wave amplitude, and a decrease in the RV lead impedance, but no patient required a lead revision due to these changes in pacing parameters. Four of the patients with pacemakers became pacemaker dependent after the procedure. 

It is interesting to speculate what the mechanism of the changes in pacing parameters was in patients undergoing TTVR. It is possible that there was traction and compression on the RV lead that resulted in microdislodgement of the lead tip or injury to the pacing lead that might progress over time. Less concerning, however, is that the changes could also have been related to a reduction in ventricular volumes and ventricular remodeling unrelated to lead integrity or the electrode-tissue interface.

There will be continued growth in TTVR and other percutaneous tricuspid valve procedures that have the potential to cause heart block or entrap preexisting pacing and defibrillator leads. Close collaboration between interventionalists and electrophysiologists will be critical to optimally manage these patients. 

Disclosures: Dr Knight has served as a paid consultant to Medtronic and was an investigator in the PULSED AF trial. In addition, he has served as a consultant, speaker, investigator, and/or has received EP fellowship grant support from Abbott, AltaThera, AtriCure, Baylis Medical, Biosense Webster, Biotronik, Boston Scientific, CVRx, Philips, and Sanofi; he has no equity or ownership in any of these companies.

References
1.    Hahn RT, Makkar R, Thourani VH, et al. Transcatheter valve replacement in severe tricuspid regurgitation. N Engl J Med. 2024;392(2):115-126. doi:10.1056/nejmoa2401918 

2.    Peigh G, Al-Kazaz M, Davidson LJ. PO-CES-07 Outcomes of entrapped right ventricular pacing or defibrillator leads following transcatheter tricuspid valve replacement with the Evoque system (Abstract). Heart Rhythm. 2025;22(4):S805. doi:10.1016/j.hrthm.2025.03.1875