Key result
TTVR with EVOQUE is linked to lead function changes in ~31% of patients with existing devices.
Why the study?
Many patients undergoing TTVR have pre-existing CIEDs, raising concerns about lead complications, but limited data exist regarding the impact of TTVR on CIED integrity and function.
What is the impact of transcatheter tricuspid valve replacement (TTVR) with the EVOQUE valve system on CIED lead function (pacing thresholds, sensing, and impedance) in patients with pre-existing cardiac implantable electronic devices?
Observational (n=32)
No
What is the impact of transcatheter tricuspid valve replacement (TTVR) with the EVOQUE valve system on CIED lead function (pacing thresholds, sensing, and impedance) in patients with pre-existing cardiac implantable electronic devices?
Transcatheter tricuspid valve replacement with the EVOQUE system in patients with pre-existing CIEDs results in lead function abnormalities in 31% of patients—including a 13% rate of suspected insulation breach—underscoring the need for close post-procedural device surveillance.
AIMS: The increasing adoption of transcatheter tricuspid valve replacement (TTVR) offers a promising therapeutic option for patients with severe tricuspid regurgitation. However, many of these patients have pre-existing cardiac implantable electronic devices (CIEDs), raising concerns about potential lead-related complications. Despite these concerns, limited data exist on the impact of TTVR on CIED integrity and function. This study aimed to evaluate the impact of TTVR on CIED lead function, including pacing thresholds, sensing, and impedance, in patients undergoing TTVR with the EVOQUE valve system. METHODS AND RESULTS: A retrospective observational study was conducted at Mayo Clinic Rochester, including 32 consecutive patients who underwent TTVR with pre-existing CIEDs. A total of 32 patients were included, with a mean age of 79.2 ± 8.4 years; 59% were female. A total of 62.5% had a permanent pacemaker, 12.5% had an implantable cardioverter-defibrillator, 15.6% had a cardiac resynchronization therapy pacemaker, and 9.4% had a cardiac resynchronization therapy defibrillator. Following TTVR, 10 (31%) of patients developed lead function changes during a median device follow-up of 210 days (IQR: 43-307 days). The right ventricular lead was primarily affected, with only one case involving an atrial lead. Neither the Ottawa score nor the anatomical lead position reliably predicted lead abnormality (P = 0.86 and P = 0.53, respectively). R-wave sensing changes were the most common lead change observed, affecting 55% of cases. In 67% of these cases, R-wave sensing alterations occurred as an isolated finding, with no significant change in impedance or thresholds, and were managed conservatively without any need for device reprogramming. Four patients (13%) had findings concerning for a lead insulation breach, in which one (3%) required a lead revision. Among five patients with follow-up exceeding 600 days, two patients exhibited a statistically significant gradual decline in impedance without other lead dysfunction, suggesting potential subclinical lead degradation. CONCLUSION: Transcatheter tricuspid valve replacement with the EVOQUE system in the setting of cardiac device leads is associated with lead function changes in 31%. The majority of lead-related changes were managed conservatively, but 13% of patients had findings concerning for an insulation breach. Future studies should focus on refining implantation techniques and defining optimal strategies for managing device-lead interactions in this population.
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Abbasi et al. (2025) conducted an observational in Severe tricuspid regurgitation with pre-existing cardiac implantable electronic devices (n=32). Transcatheter tricuspid valve replacement (TTVR) with the EVOQUE system was evaluated on Significant lead function changes post-TTVR (pacing thresholds, sensing, and impedance). Transcatheter tricuspid valve replacement with the EVOQUE system in patients with pre-existing cardiac devices was associated with lead function changes in 31% of cases, most commonly R-wave sensing loss, and a 13% incidence of lead insulation breach.
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