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People undergoing transcatheter tricuspid valve replacement (TTVR) to avoid redo valve surgery still had fairly good mid-term outcomes despite the presence of pacemaker leads, according to registry data.

TTVR resulted in documented lead complications in three out of 28 cases: one patient had the right ventricular (RV) lead dislodged, and two experienced lead failure. The other 25 patients kept their RV leads intact and functioning over a median 15 months of follow-up, reported a group led by Jason Anderson, MD, of Mayo Clinic in Rochester, Minnesota.

Three patients died of heart failure unrelated to the procedure or pacemaker function, Anderson's team reported online in .

"In this preliminary study, we found that TTVR in the setting of a trans-TV [tricuspid valve] pacemaker lead was performed safely, with a low risk for periprocedural complications, offering a transcatheter alternative to redo surgical TV replacement with or without lead extraction," the authors said.

The risk of lead failure after TTVR with lead entrapment was "low" but still merits impedance testing and ongoing evaluation of the lead threshold, the researchers suggested. "The jailing maneuver results in fixation of the lead by a mechanical force, which may lead to insulation or conductor failure over time from repetitive trauma or damage from the surrounding structures during the cardiac cycle."

The investigators identified 329 patients in the VIVID registry who had undergone TTVR within a surgically placed tricuspid valve bioprosthesis or annuloplasty ring. Of those, 128 had prior pacing systems already in place, 31 of whom had transvenous leads passing through the tricuspid valve.

The majority had TTVR performed with the RV lead entrapped between the transcatheter tricuspid valve implant and the surgical valve or the repaired tricuspid valve. Three patients had the RV lead extracted before TTVR and were therefore not counted in the main analysis.

Overall, the 28 patients with entrapped RV leads shared a similar incidence of death, tricuspid valve reintervention, and tricuspid valve dysfunction with peers lacking pacing leads, said Anderson and colleagues.

This is notable because "patients with degenerated biological TV prostheses with active pacemakers are not an exotic and rare phenomenon, but instead, an important and complex group of patients for whom the development of valid treatment options with reasonable periprocedural risk is warranted," wrote Can Öztürk, MD, of University Hospital Bonn in Germany, and colleagues, in an .

"Up to now, treatment options for patients with a degenerated TV prosthesis and PL [pacing lead] have been uncertain, given the often prohibitively high surgical risk of a redo procedure and the anticipated technical issues potentially related to a catheter-based approach," Öztürk and co-authors said.

The good news, they said, was the relatively low 15% mortality rate at 2 years in a cohort that tended to have severe heart failure, with many of the patients already having one or two prior surgical procedures, and nearly half the group presenting with congenital heart disease.

"Although accurate information on periprocedural mortality is lacking, it may be speculated that the complication rate may be lower with catheter-based redo TV procedures compared with the surgical open-heart approach," the editorialists wrote. The bad news, on the other hand, was the 10.7% rate of lead complications after TTVR.

"One could argue that these patients do not have many or any other treatment options and that a 10% risk should be considered as acceptable. On the other hand, it appears to be of utmost importance to assess symptoms and their causality as well as comorbidities pre-procedurally," Öztürk and co-authors said. "In a patient with 100% pacemaker dependence in whom TV disease is not the most definite cause of the patient's complaints, a TV procedure should not risk the PLs in 10% of the cases. In those patients, repositioning of the PLs beforehand or declination of the TV procedure are the more obvious strategies."

In the study, TTVR recipients who had transvenous leads in the VIVID registry had a median age of 56, and 64% were women. This group underwent the procedure about 10 years after surgical tricuspid valve repair (valve-in-ring) or replacement (valve-in-valve).

One concern of jailing pacemaker leads in TTVR is how to remove them in case of thrombus or infection, Anderson and co-authors noted. The ability to remove or cut leads at the access site may require special attention as the prevalence of TTVR in the setting of pacemaker leads continues to rise, the investigators said.

The team acknowledged that longer follow-up will be necessary to determine whether patients who undergo TTVR in the setting of transvenous pacing leads are at risk for accelerated valve dysfunction. The minority of patients who had pacing leads jailed by TTVR within annuloplasty rings should also be followed more closely, the researchers added.

"In addition, the entrapment of PL may cause some late-onset complications such as insulation or conductor failure due to chronic mechanical interference, which may occur over the years," Öztürk and co-authors said. Furthermore, they said, operators should consider innovations in tricuspid valve surgery (such as beating-heart and minimally invasive procedures) and weigh those against a catheter-based approach.

"In any event, it has to be stated that this post hoc analysis is far from proving the superiority of a catheter-based therapy over surgical treatment," the editorialists noted. "This would require a prospective randomized study."

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