Key result
Electroanatomical mapping-guided device implantation resulted in a similar average length of stay compared to conventional fluoroscopy (1.20 vs 1.47 days; P=0.10) and markedly lower radiation.
Why the study?
Fluoroscopy-minimizing 3-D navigation for device implantation offers reduced radiation exposure, but had primarily been reported in case reports and not widely utilized by electrophysiologists.
Does electroanatomical mapping (EAM)-guided device implantation reduce radiation exposure while maintaining safety and efficacy compared to conventional fluoroscopic guidance in patients undergoing device implantation?
Cohort (n=33)
Does electroanatomical mapping (EAM)-guided device implantation reduce radiation exposure while maintaining safety and efficacy compared to conventional fluoroscopic guidance in patients undergoing device implantation?
Absolute Event Rate: 1.2% vs 1.47%
p-value: p=0.10
EAM-guided device implantation is a safe and effective alternative to conventional fluoroscopy, significantly reducing radiation exposure without increasing complications or length of stay.
Supports feasibility of minimal-fluoroscopy implantation in select patients; leaves open need for prospective safety and efficacy data.
BACKGROUND: The conventional method of device implantation requires fluoroscopic guidance. With the guidance of three-dimensional (3-D) navigation systems, devices can be implanted with minimal use of fluoroscopy. To date, this technique has been reported in several case reports in young, pregnant patients. However, this technique has not been widely utilized by electrophysiologists, despite offering several benefits, including reduced radiation exposure for the patient and the operator. METHODS: In this study, we evaluated 18 patients who successfully underwent device implantation with limited use of fluoroscopy under the guidance of the EnSite Precision 3-D mapping navigation system (Abbott, St. Paul, MN, USA). In most of the patients, the total fluoroscopy time was 1 s, accounted by a single postprocedural frame to insure appropriate lead placement. RESULTS: A total of 19 leads were implanted in 18 patients (14 male, four female) using the electroanatomical mapping (EAM)-guided technique. A total of 19 leads were implanted in 15 patients (10 male, five female) using the conventional method. The average length of stay was 1.20 days in the EAM group compared to 1.47 days in the conventional group (P = .10). Majority of the devices implanted in both groups were single-chamber implantable cardiac defibrillators (VVI ICD, Abbott) implanted for cardiomyopathy with left ventricular ejection fraction persistently below 35%, including 88% (16/18) in the EAM group compared to 73% (11/15) in the conventional group. No periprocedural or immediate postprocedure complications were reported in either group. Device parameters, including impedance, capture time, and capture voltage, showed no significant difference in either group. Total radiation time and radiation dose were markedly lower in the EAM-guided implantation group. CONCLUSIONS: In patients who meet appropriate criteria for device implantation, the use of EAM system offers a safe, practical, efficacious alternative method to device implantation, with significant reduction in radiation time and dose.
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Patel et al. (2019) conducted a cohort in Cardiomyopathy requiring device implantation (n=33). Electroanatomical mapping (EAM)-guided device implantation vs. Conventional method (fluoroscopic guidance) was evaluated on Average length of stay (p=0.10). Electroanatomical mapping-guided device implantation resulted in a similar average length of stay compared to conventional fluoroscopy (1.20 vs 1.47 days; P=0.10) and markedly lower radiation.
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