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The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.
- Source :
-
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2020 Apr 01; Vol. 95 (5), pp. 1051-1056. Date of Electronic Publication: 2019 Sep 02. - Publication Year :
- 2020
-
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.<br />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.<br />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.<br />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.<br />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.<br /> (© 2019 Wiley Periodicals, Inc.)
- Subjects :
- Aged
Aged, 80 and over
Equipment Design
Female
Heart Rate
Humans
Male
Patient Safety
Perioperative Care adverse effects
Registries
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
United States
Ventricular Function, Right
Cardiac Pacing, Artificial adverse effects
Cardiac Surgical Procedures adverse effects
Pacemaker, Artificial
Perioperative Care instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 95
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 31478304
- Full Text :
- https://doi.org/10.1002/ccd.28476