Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Near-Zero-Fluoroscopy Ablation of Atrial fibrillation without ICE or non-fluoroscopic tracking systems: First insights from the SHORT LOOK registry
M. Borlich1, E.-M. Jungclaus1, S. Groschke1, R. Weinert1, G. Richardt2, L. Iden1
1Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg; 2Herz- Gefäßzentrum, Segeberger Kliniken GmbH, Bad Segeberg;

Background:
Catheter ablation of left atrial arrhythmias is a widely used, safe and effective rhythm-control strategy. Utilization of fluoroscopy carries the risk of deterministic or stochastic radiation damage to both patient and operators. It has been shown that fluoroscopy dose and duration can be significantly reduced by utilization of intracardiac ultrasound (ICE) or nonfluoroscopic catheter tracking systems like MediGuide. However, both methods are of limited availability due to high costs and/or necessity of extensive training.

Further, increased procedural duration has been associated with higher complication rates. Due to increasing numbers of patients undergoing ablation therapy and limitation of resources, short procedural times and are warranted without compromising procedural outcome or patient’s safety.

Objective:
To demonstrate that in patients undergoing first time left atrial ablation, the use of an optimized lean workflow for near-zero-fluoroscopy ablation is not inferior to standard ablation procedure with respect to efficacy and a combined safety endpoint. The study is designed as investigator-driven, prospective, single-arm registry with planned 500 prospective treated patients compared with data from ESC EHRA EORP Atrial Fibrillation Ablation Long-Term (AFA LT) Registry. All patients will be followed for 3 and 12 months for evaluation of efficacy and safety endpoints.

Methods:
The first 100 prospective treated patients of our SHORT LOOK registry with first AF ablation are examined with regard to a combined safety endpoint of procedure-related death, cardiovascular, neurological or vascular event. All patients are received RF ablation using CARTO 3 and very low dose imaging protocol of an ARTIS zee angiography system operated at 8 nGy detector entrance dose per fluoroscopy pulse and 3 frames per second.

Workflow: All patients were treated with the CARTO 3 System by three different operators. Standard workflow consisted of: Nonfluoroscopic placement of CS catheter by previous creation of a 3D-Matrix with the ablation catheter followed by single transseptal puncture with fluoroscopy guidance and passage of the ablation catheter along the guidewire resulting in double transseptal access. Afterwards, 3D-FAM-Maps were created without additional imaging and PVI was done according to the CLOSE-Protocol described elsewhere. Deployment of additional lesions was possible at the operator’s discretion.

Results:
Baseline characteristics of patients are shown in Tab. 1;
 

distribution of procedural and fluoroscopy time and dose are shown in Fig. 1 and 2 

 respectively. Procedural data and in-hospital complications are shown in Tab. 2.


In the first 100 patients, ablation with less than 1 minute of fluoroscopy was feasible in 93 % of patients. Median procedural time was 55.5 minutes, median fluoroscopy dose was 9.3 µGy * m
2. Complete pulmonary vein isolation was achieved in all patients. In 25 patients, additional ablation lesions were deployed.

Out of the first 100 patients of the SHORT LOOK registry, one patient suffered a serious adverse event (pericardial tamponade).

Conclusion:

In this cohort, a lean, near-zero fluoroscopy workflow was feasible and associated with favorable procedure times without compromising the procedural safety profile. As the follow-up for 12 month is still ongoing, data regarding the efficacy endpoint is unavailable at present. 


https://dgk.org/kongress_programme/jt2022/aP502.html