Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study

Tatyana Storozhenko; Giulio Russo; Marc Vanderheyden; Ole De Backer; Michael Rosseel; Hadewich Hermans; Philippe Vanduynhoven; Tom De Potter; Guy Van Camp; Marianna Adamo; Edoardo Pancaldi; Rodrigo Estevez-Loureiro; Horst Sievert; Kerstin Piayda; Darren Mylotte; Stijn Lochy; Joerg Hausleiter; Lukas Stolz; Thomas Nestelberger; Max Wagener; Tiffany Patterson; Joshua Wilcox; Martin J Swaans; Leo Timmers; Martijn Vrijkorte; Maurizio Taramasso; Liesbeth Rosseel

doi:10.1016/j.jacep.2025.11.003

Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study

Tatyana Storozhenko, Giulio Russo, Marc Vanderheyden, Ole De Backer, Michael Rosseel, Hadewich Hermans, Philippe Vanduynhoven, Tom De Potter, Guy Van Camp, Marianna Adamo, Edoardo Pancaldi, Rodrigo Estevez-Loureiro, Horst Sievert, Kerstin Piayda, Darren Mylotte, Stijn Lochy, Joerg Hausleiter, Lukas Stolz, Thomas Nestelberger, Max WagenerTiffany Patterson, Joshua Wilcox, Martin J Swaans, Leo Timmers, Martijn Vrijkorte, Maurizio Taramasso, Liesbeth Rosseel^*

^*Corresponding author af dette arbejde

Afdeling for Hjertesygdomme HJE

Abstract

BACKGROUND: Tricuspid transcatheter edge-to-edge repair (T-TEER) is an important treatment option for symptomatic severe tricuspid valve regurgitation. Interaction with a preexisting right ventricular (RV) pacing lead can result in clinically significant RV lead dysfunction over time.

OBJECTIVES: The goal of this study was to evaluate the 2-year safety and function of preexisting RV leads after T-TEER.

METHODS: The Tri-LEAD (Tricuspid Right Ventricular lead entrapment in transcatheter tricuspid interventions) study was a retrospective multicenter international registry of 146 patients who underwent T-TEER with an RV lead in situ from 2015 to 2023. Primary outcome was RV lead dysfunction after T-TEER at 2 years (defined as change in RV lead function, dislodgement, or fracture) and need for intervention due to RV lead dysfunction or cardiac complication.

RESULTS: Mean patient age was 78.1 ± 8.6 years, and 54% were male. Over a median follow-up of 557 days (Q1-Q3: 278-966 days), 10 patients (6.8%) had an impedance change >200 Ω and 2 patients (1.4%) had a threshold change ≥1 V, with no observed cases of RV lead fracture, dislodgement, cardiac structure perforation, or pacemaker-related re-interventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted SHR: 1.39; 95% CI: 0.64 to 3.02; P = 0.41). Over time, changes in RV lead sensing (-0.53 mV/year; 95% CI: -1.15 to 0.08; P = 0.094), impedance (-2.4 Ω/year; 95% CI: -15.4 to 10.6; P = 0.72), and threshold (-0.011 V/year; 95% CI: -0.052 to 0.031; P = 0.62) were minimal and not clinically significant.

CONCLUSIONS: T-TEER has no detrimental impact on the performance of transvenous RV leads in the short term or midterm.

Originalsprog	Engelsk
Tidsskrift	JACC. Clinical electrophysiology
ISSN	2405-5018
DOI	https://doi.org/10.1016/j.jacep.2025.11.003
Status	E-pub ahead of print - 18 dec. 2025

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10.1016/j.jacep.2025.11.003

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Storozhenko, T., Russo, G., Vanderheyden, M., De Backer, O., Rosseel, M., Hermans, H., Vanduynhoven, P., De Potter, T., Van Camp, G., Adamo, M., Pancaldi, E., Estevez-Loureiro, R., Sievert, H., Piayda, K., Mylotte, D., Lochy, S., Hausleiter, J., Stolz, L., Nestelberger, T., ... Rosseel, L. (2025). Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study. JACC. Clinical electrophysiology. Advance online publication. https://doi.org/10.1016/j.jacep.2025.11.003

Storozhenko, T, Russo, G, Vanderheyden, M, De Backer, O, Rosseel, M, Hermans, H, Vanduynhoven, P, De Potter, T, Van Camp, G, Adamo, M, Pancaldi, E, Estevez-Loureiro, R, Sievert, H, Piayda, K, Mylotte, D, Lochy, S, Hausleiter, J, Stolz, L, Nestelberger, T, Wagener, M, Patterson, T, Wilcox, J, Swaans, MJ, Timmers, L, Vrijkorte, M, Taramasso, M & Rosseel, L 2025, 'Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study', JACC. Clinical electrophysiology. https://doi.org/10.1016/j.jacep.2025.11.003

@article{9e6356e9d14e4a44b5bd5e1ec6fd6b60,

title = "Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study",

abstract = "BACKGROUND: Tricuspid transcatheter edge-to-edge repair (T-TEER) is an important treatment option for symptomatic severe tricuspid valve regurgitation. Interaction with a preexisting right ventricular (RV) pacing lead can result in clinically significant RV lead dysfunction over time.OBJECTIVES: The goal of this study was to evaluate the 2-year safety and function of preexisting RV leads after T-TEER.METHODS: The Tri-LEAD (Tricuspid Right Ventricular lead entrapment in transcatheter tricuspid interventions) study was a retrospective multicenter international registry of 146 patients who underwent T-TEER with an RV lead in situ from 2015 to 2023. Primary outcome was RV lead dysfunction after T-TEER at 2 years (defined as change in RV lead function, dislodgement, or fracture) and need for intervention due to RV lead dysfunction or cardiac complication.RESULTS: Mean patient age was 78.1 ± 8.6 years, and 54% were male. Over a median follow-up of 557 days (Q1-Q3: 278-966 days), 10 patients (6.8%) had an impedance change >200 Ω and 2 patients (1.4%) had a threshold change ≥1 V, with no observed cases of RV lead fracture, dislodgement, cardiac structure perforation, or pacemaker-related re-interventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted SHR: 1.39; 95% CI: 0.64 to 3.02; P = 0.41). Over time, changes in RV lead sensing (-0.53 mV/year; 95% CI: -1.15 to 0.08; P = 0.094), impedance (-2.4 Ω/year; 95% CI: -15.4 to 10.6; P = 0.72), and threshold (-0.011 V/year; 95% CI: -0.052 to 0.031; P = 0.62) were minimal and not clinically significant.CONCLUSIONS: T-TEER has no detrimental impact on the performance of transvenous RV leads in the short term or midterm.",

keywords = "defibrillator lead, pacemaker lead, RV lead entrapment, transcatheter tricuspid valve intervention, tricuspid edge-to-edge repair, tricuspid regurgitation",

author = "Tatyana Storozhenko and Giulio Russo and Marc Vanderheyden and {De Backer}, Ole and Michael Rosseel and Hadewich Hermans and Philippe Vanduynhoven and {De Potter}, Tom and {Van Camp}, Guy and Marianna Adamo and Edoardo Pancaldi and Rodrigo Estevez-Loureiro and Horst Sievert and Kerstin Piayda and Darren Mylotte and Stijn Lochy and Joerg Hausleiter and Lukas Stolz and Thomas Nestelberger and Max Wagener and Tiffany Patterson and Joshua Wilcox and Swaans, {Martin J} and Leo Timmers and Martijn Vrijkorte and Maurizio Taramasso and Liesbeth Rosseel",

year = "2025",

month = dec,

day = "18",

doi = "10.1016/j.jacep.2025.11.003",

language = "English",

journal = "JACC. Clinical electrophysiology",

issn = "2405-5018",

publisher = "Elsevier USA",

}

TY - JOUR

T1 - Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions

T2 - The Tri-LEAD Study

AU - Storozhenko, Tatyana

AU - Russo, Giulio

AU - Vanderheyden, Marc

AU - De Backer, Ole

AU - Rosseel, Michael

AU - Hermans, Hadewich

AU - Vanduynhoven, Philippe

AU - De Potter, Tom

AU - Van Camp, Guy

AU - Adamo, Marianna

AU - Pancaldi, Edoardo

AU - Estevez-Loureiro, Rodrigo

AU - Sievert, Horst

AU - Piayda, Kerstin

AU - Mylotte, Darren

AU - Lochy, Stijn

AU - Hausleiter, Joerg

AU - Stolz, Lukas

AU - Nestelberger, Thomas

AU - Wagener, Max

AU - Patterson, Tiffany

AU - Wilcox, Joshua

AU - Swaans, Martin J

AU - Timmers, Leo

AU - Vrijkorte, Martijn

AU - Taramasso, Maurizio

AU - Rosseel, Liesbeth

PY - 2025/12/18

Y1 - 2025/12/18

N2 - BACKGROUND: Tricuspid transcatheter edge-to-edge repair (T-TEER) is an important treatment option for symptomatic severe tricuspid valve regurgitation. Interaction with a preexisting right ventricular (RV) pacing lead can result in clinically significant RV lead dysfunction over time.OBJECTIVES: The goal of this study was to evaluate the 2-year safety and function of preexisting RV leads after T-TEER.METHODS: The Tri-LEAD (Tricuspid Right Ventricular lead entrapment in transcatheter tricuspid interventions) study was a retrospective multicenter international registry of 146 patients who underwent T-TEER with an RV lead in situ from 2015 to 2023. Primary outcome was RV lead dysfunction after T-TEER at 2 years (defined as change in RV lead function, dislodgement, or fracture) and need for intervention due to RV lead dysfunction or cardiac complication.RESULTS: Mean patient age was 78.1 ± 8.6 years, and 54% were male. Over a median follow-up of 557 days (Q1-Q3: 278-966 days), 10 patients (6.8%) had an impedance change >200 Ω and 2 patients (1.4%) had a threshold change ≥1 V, with no observed cases of RV lead fracture, dislodgement, cardiac structure perforation, or pacemaker-related re-interventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted SHR: 1.39; 95% CI: 0.64 to 3.02; P = 0.41). Over time, changes in RV lead sensing (-0.53 mV/year; 95% CI: -1.15 to 0.08; P = 0.094), impedance (-2.4 Ω/year; 95% CI: -15.4 to 10.6; P = 0.72), and threshold (-0.011 V/year; 95% CI: -0.052 to 0.031; P = 0.62) were minimal and not clinically significant.CONCLUSIONS: T-TEER has no detrimental impact on the performance of transvenous RV leads in the short term or midterm.

AB - BACKGROUND: Tricuspid transcatheter edge-to-edge repair (T-TEER) is an important treatment option for symptomatic severe tricuspid valve regurgitation. Interaction with a preexisting right ventricular (RV) pacing lead can result in clinically significant RV lead dysfunction over time.OBJECTIVES: The goal of this study was to evaluate the 2-year safety and function of preexisting RV leads after T-TEER.METHODS: The Tri-LEAD (Tricuspid Right Ventricular lead entrapment in transcatheter tricuspid interventions) study was a retrospective multicenter international registry of 146 patients who underwent T-TEER with an RV lead in situ from 2015 to 2023. Primary outcome was RV lead dysfunction after T-TEER at 2 years (defined as change in RV lead function, dislodgement, or fracture) and need for intervention due to RV lead dysfunction or cardiac complication.RESULTS: Mean patient age was 78.1 ± 8.6 years, and 54% were male. Over a median follow-up of 557 days (Q1-Q3: 278-966 days), 10 patients (6.8%) had an impedance change >200 Ω and 2 patients (1.4%) had a threshold change ≥1 V, with no observed cases of RV lead fracture, dislodgement, cardiac structure perforation, or pacemaker-related re-interventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted SHR: 1.39; 95% CI: 0.64 to 3.02; P = 0.41). Over time, changes in RV lead sensing (-0.53 mV/year; 95% CI: -1.15 to 0.08; P = 0.094), impedance (-2.4 Ω/year; 95% CI: -15.4 to 10.6; P = 0.72), and threshold (-0.011 V/year; 95% CI: -0.052 to 0.031; P = 0.62) were minimal and not clinically significant.CONCLUSIONS: T-TEER has no detrimental impact on the performance of transvenous RV leads in the short term or midterm.

KW - defibrillator lead

KW - pacemaker lead

KW - RV lead entrapment

KW - transcatheter tricuspid valve intervention

KW - tricuspid edge-to-edge repair

KW - tricuspid regurgitation

UR - http://www.scopus.com/inward/record.url?scp=105027260117&partnerID=8YFLogxK

U2 - 10.1016/j.jacep.2025.11.003

DO - 10.1016/j.jacep.2025.11.003

M3 - Journal article

C2 - 41411471

SN - 2405-5018

JO - JACC. Clinical electrophysiology

JF - JACC. Clinical electrophysiology

ER -

Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study

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