Key result
3D printing-guided LuX-Valve TTVR achieves 100% procedural success in severe pacemaker lead-induced TR.
Why the study?
Lead-induced tricuspid regurgitation is a complication following permanent pacemaker implantation, but its clinical characteristics and the effect of 3D printing-guided transcatheter tricuspid valve replacement remained to be studied.
Does transcatheter tricuspid valve replacement (TTVR) with 3D printing guidance improve clinical and echocardiographic outcomes in patients with severe tricuspid regurgitation induced by permanent pacemaker leads?
Observational (n=6)
No
Does transcatheter tricuspid valve replacement (TTVR) with 3D printing guidance improve clinical and echocardiographic outcomes in patients with severe tricuspid regurgitation induced by permanent pacemaker leads?
Transcatheter tricuspid valve replacement using the LuX-Valve with 3D printing guidance is a feasible and effective treatment for severe pacemaker lead-induced tricuspid regurgitation, yielding sustained improvements at 2 years.
Answers are grounded in this paper and cite their sources.
Supports feasibility in lead-induced TR; hypothesis-generating and should not yet change practice.
Background: Lead-induced tricuspid regurgitation is one of the complications after permanent pacemaker implantation (PPI) and refers to tricuspid regurgitation (TR) caused by the lead in the right ventricle (RV). Objectives: To study the clinical characteristics of severe TR after PPI and the effect of transcatheter tricuspid valve replacement (TTVR) with the guidance of 3-dimensional (3D) printing. Methods: This study was a single-center, descriptive study. Six patients with severe TR after PPI were enrolled in Xijing Hospital from January 2020 to May 2020. Before TTVR, the 3D printed tricuspid valve (TV) model was used for evaluation in the bench test. LuX-Valve was implanted under the guidance of TEE and x-ray fluoroscopy, and all patients underwent transatrial access. Six patients' data were collected at baseline, before discharge, and 6 months, 1 year and 2 years after TTVR. Results: The LuX-Valve was successfully implanted in 6 patients, TR was significantly reduced to ≤2+, and no deaths or cardiopulmonary bypass occurred during procedures. Three cases were caused by TV expansion: Patient #4 had TR caused by lead adhesion to TV, Patient #2 had TR caused by lead winding, and Patient #6 had TR caused by lead impingement on TV. During the 2-year follow-up, TTE revealed that 5 patients had no/trace regurgitation, and one patient (Patient #5) had mild regurgitation. All 6 patients (100.0%) reached primary endpoints. Conclusion: : ClinicalTrials.gov Protocol Registration System (NCT02917980).
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Mao et al. (2023) conducted an observational in Severe tricuspid regurgitation induced by permanent pacemaker lead (n=6). Transcatheter tricuspid valve replacement (TTVR) with LuX-Valve guided by 3D printing was evaluated on Successful surgery (successful implantation, TR severity reduced by ≥2, TV pressure gradient ≤ 6 mmHg, and no major adverse events). Transcatheter tricuspid valve replacement with the LuX-Valve guided by 3D printing was successfully performed in 100% of patients with severe pacemaker lead-induced tricuspid regurgitation.
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