The Impact of Preexisting Cardiac Implantable Electronic Devices on the Safety of Transcatheter Tricuspid Valve Interventions: A Systematic Review and Meta-Analysis.
13 affiliations
- 1College of Medicine, Alfaisal University, Riyadh 11533, Saudi Arabia.
- 2College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia.
- 3College of Medicine, AlMaarefa University, Riyadh 11597, Saudi Arabia.
- 4Adult Cardiology Department, Armed Forces Hospital Southern Region, Khamis Mushait 62413, Saudi Arabia.
- 5College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah 22384, Saudi Arabia.
- 6Prince Sultan Cardiac Centre-Qassim, Qassim Health Cluster, Buraydah 52366, Saudi Arabia.
- 7College of Medicine, King Khalid University, Abha 61421, Saudi Arabia.
- 8College of Medicine, Fakeeh College for Medical Sciences, Jeddah 23323, Saudi Arabia.
- 9Internal Medicine, Security Forces Hospital Riyadh, Northern Border University, Riyadh 11481, Saudi Arabia.
- 10College of Medicine, Umm Al-Qura University, Makkah 21955, Saudi Arabia.
- 11College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh 11481, Saudi Arabia.
- 12Faculty of Medicine, Al-Azhar University, Cairo 11884, Egypt.
- 13Department of Cardiology, King Fahad Medical City, Riyadh 11525, Saudi Arabia.
Abstract
Background
Tricuspid regurgitation (TR) increases mortality but remains undertreated due to high surgical risks. Transcatheter tricuspid valve interventions (TTVI) offer safer alternatives, improving functional status and quality of life. However, many candidates for TTVI have trans-tricuspid CIED leads that may interfere with procedural imaging and device deployment and may be exposed to dislodgement, entrapment, or jailing. Evidence regarding both clinical outcomes and postprocedural CIED function in this population remains limited. Existing trial evidence for this population is scarce, requiring further safety analysis. To our knowledge, this is the first meta-analysis to address the comparative risk of complications and residual TR in patients with vs. without CIEDs.Methods
We searched for relevant articles up to March 2026 from PubMed, Scopus, Cochrane Library, and Web of Science. Two independent reviewers extracted data from the selected studies, including baseline information, outcomes, comorbidities, hospitalization metrics, TR severity, and complications. All data analyses were performed using R version 4.4.1.Results
Ten studies comprising 5415 patients were included. Nine comparative studies contributed to the quantitative synthesis, whereas one single-arm study contributed only to the narrative synthesis of CIED-specific mechanical and electrical outcomes. In patients undergoing TTVI, across two studies, patients with CIEDs had a nominally lower risk of single-leaflet device attachment (RR 0.34, 95% CI 0.12-0.94; nominal p = 0.037); however, this exploratory finding should be considered hypothesis-generating. However, no statistically significant differences were observed between groups for cardiovascular death (RR 1.30, p = 0.815), device embolization (RR 1.62, p = 0.666), device malposition (RR 1.10, p = 0.909), stroke (RR 0.52, p = 0.335), hospitalization for heart failure (RR 1.02, p = 0.931), in-hospital mortality (RR 1.02, p = 0.959), major adverse events (RR 0.74, p = 0.635), major bleeding (RR 0.70, p = 0.187), or residual tricuspid regurgitation of mild (RR 0.98, p = 0.686) or moderate severity (RR 1.01, p = 0.646). CIED-specific outcomes were reported heterogeneously. Lead function was generally preserved after T-TEER in carefully selected patients, whereas studies of TTVR with jailed leads reported lead failure or malfunction ranging from 5.8% to 21% in individual cohorts.Conclusions
Among the comparative outcomes available for quantitative pooling, no statistically significant differences were detected between patients with and without CIEDs for most procedural and postprocedural outcomes. However, CIED-specific risks differed according to the intervention. Lead function was generally preserved after T-TEER in carefully selected patients, whereas lead jailing during TTVR was associated with clinically relevant lead malfunction in some cohorts. Therefore, the absence of significant differences in pooled clinical outcomes should not be interpreted as evidence that TTVI does not affect CIED function.
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BibTeX
@article{almasri2026impact,
title = {{The Impact of Preexisting Cardiac Implantable Electronic Devices on the Safety of Transcatheter Tricuspid Valve Interventions: A Systematic Review and Meta-Analysis.}},
author = {Yaman Almasri and Abdulrahman A Sayed and Lama Alzahrani and Saad Mohammed Abdullah Alqahtani and Renad Saeed Algarni and Amro Badra and Majid Naif Alharbi and Ayman Al Sibai and Muath Alqahtani and Mohammed Alshareef and Adel Turki D Alenezi and Saja Faisal Alzahrani and Bader Mansour Alotaibi and Ali Bakr and Muhammad Azam Shah},
journal = {Journal of cardiovascular development and disease},
year = {2026},
month = sep,
doi = {10.3390/jcdd13100478},
url = {https://europepmc.org/article/MED/42930874},
note = {CC BY},
}
RIS
TY - JOUR
TI - The Impact of Preexisting Cardiac Implantable Electronic Devices on the Safety of Transcatheter Tricuspid Valve Interventions: A Systematic Review and Meta-Analysis.
AU - Yaman Almasri
AU - Abdulrahman A Sayed
AU - Lama Alzahrani
AU - Saad Mohammed Abdullah Alqahtani
AU - Renad Saeed Algarni
AU - Amro Badra
AU - Majid Naif Alharbi
AU - Ayman Al Sibai
AU - Muath Alqahtani
AU - Mohammed Alshareef
AU - Adel Turki D Alenezi
AU - Saja Faisal Alzahrani
AU - Bader Mansour Alotaibi
AU - Ali Bakr
AU - Muhammad Azam Shah
PY - 2026
DA - 2026/09/23
JO - Journal of cardiovascular development and disease
DO - 10.3390/jcdd13100478
UR - https://europepmc.org/article/MED/42930874
AB - Background Tricuspid regurgitation (TR) increases mortality but remains undertreated due to high surgical risks. Transcatheter tricuspid valve interventions (TTVI) offer safer alternatives, improving functional status and quality of life. However, many candidates for TTVI have trans-tricuspid CIED leads that may interfere with procedural imaging and device deployment and may be exposed to dislodgement, entrapment, or jailing. Evidence regarding both clinical outcomes and postprocedural CIED function in this population remains limited. Existing trial evidence for this population is scarce, requiring further safety analysis. To our knowledge, this is the first meta-analysis to address the comparative risk of complications and residual TR in patients with vs. without CIEDs.Methods We searched for relevant articles up to March 2026 from PubMed, Scopus, Cochrane Library, and Web of Science. Two independent reviewers extracted data from the selected studies, including baseline information, outcomes, comorbidities, hospitalization metrics, TR severity, and complications. All data analyses were performed using R version 4.4.1.Results Ten studies comprising 5415 patients were included. Nine comparative studies contributed to the quantitative synthesis, whereas one single-arm study contributed only to the narrative synthesis of CIED-specific mechanical and electrical outcomes. In patients undergoing TTVI, across two studies, patients with CIEDs had a nominally lower risk of single-leaflet device attachment (RR 0.34, 95% CI 0.12-0.94; nominal p = 0.037); however, this exploratory finding should be considered hypothesis-generating. However, no statistically significant differences were observed between groups for cardiovascular death (RR 1.30, p = 0.815), device embolization (RR 1.62, p = 0.666), device malposition (RR 1.10, p = 0.909), stroke (RR 0.52, p = 0.335), hospitalization for heart failure (RR 1.02, p = 0.931), in-hospital mortality (RR 1.02, p = 0.959), major adverse events (RR 0.74, p = 0.635), major bleeding (RR 0.70, p = 0.187), or residual tricuspid regurgitation of mild (RR 0.98, p = 0.686) or moderate severity (RR 1.01, p = 0.646). CIED-specific outcomes were reported heterogeneously. Lead function was generally preserved after T-TEER in carefully selected patients, whereas studies of TTVR with jailed leads reported lead failure or malfunction ranging from 5.8% to 21% in individual cohorts.Conclusions Among the comparative outcomes available for quantitative pooling, no statistically significant differences were detected between patients with and without CIEDs for most procedural and postprocedural outcomes. However, CIED-specific risks differed according to the intervention. Lead function was generally preserved after T-TEER in carefully selected patients, whereas lead jailing during TTVR was associated with clinically relevant lead malfunction in some cohorts. Therefore, the absence of significant differences in pooled clinical outcomes should not be interpreted as evidence that TTVI does not affect CIED function.
SN - 2308-3425
ER -