The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.
Document Type
Article
Publication Title
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Abstract
OBJECTIVES: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead.
BACKGROUND: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability.
METHODS: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed.
RESULTS: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment.
CONCLUSION: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.
First Page
1051
Last Page
1056
DOI
10.1002/ccd.28476
Publication Date
4-1-2020
Recommended Citation
Nazif TM, Chen S, Codner P, Grossman PM, Menees DS, Sanchez CE, Yakubov SJ, White J, Kapadia S, Whisenant BK, Forrest JK, Krishnaswamy A, Arshi A, Orford JL, Leon MB, Dizon JM, Kodali SK, Chetcuti SJ. The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions. Catheter Cardiovasc Interv. 2020 Apr 1;95(5):1051-1056. doi: 10.1002/ccd.28476. Epub 2019 Sep 2. PMID: 31478304.