Real-world safety results on pulsed-field ablation with pentaspline catheter

The MANIFEST-PF survey demonstrated that pulsed-field ablation (PFA) with the pentaspline catheter achieved pulmonary vein isolation (PVI) in 99.9% of the investigated real-world cases. The safety profile of this technique was reassuring with regard to oesophageal damage and consistent with that of preferential tissue ablation.

PFA has shown to be safe and efficacious in first-in-human trials, but the sample sizes of these trials were rather limited [1,2]. In the current retrospective study, Dr Vivek Reddy (Mount Sinai Hospital, NY, USA) and colleagues aimed to assess the real-world performance of the pentaspline PFA catheter [3]. More specifically, the objectives were to assess the safety, effectiveness, and usage of this tool in clinical practice. A survey was sent to 24 centres to gather data from 90 operators on 1,758 patients who underwent PFA.

An indication of paroxysmal atrial fibrillation (AF) was detected in 57.5% of the patients and 35.2% had an indication of persistent AF. The average procedure time was 65 minutes and 15.8% of the patients were discharged on the day of the procedure.

The most commonly used pre-procedural imaging techniques were transoesophageal echocardiogram (TEE) and CT imaging. During the procedure, fluoroscopy and intracardiac echocardiography (ICE) were frequently utilised. Notably, MRI was not used as a pre-procedural imaging technique in 70.8% of the cases. The use of electro-anatomical mapping was divided among operators: 35–40% of the operators always used this technique, but a similar amount of surgeons never used this method during PFA ablation with the pentaspline catheter. Besides PVI, roofline and left atrial posterior wall lesion sets were used by 12.5% of the operators.

The mean PVI success rate was 99.9%, ranging between 98.9% and 100% across centres. In terms of safety, major PFA-specific complications were limited. No cases of oesophageal fistulae, dysmotility, pulmonary vein stenosis, or persistent phrenic nerve injury were observed. One case of treatment-related coronary artery spasm was reported. In 8 patients, transient phrenic nerve injury was seen. However, these events were considered to be minor PFA-specific events. Furthermore, pericardial tamponade (0.97%), stroke (0.40%), and vascular complications requiring surgery (0.23%) were the most common major non-PFA specific adverse events. One patient who experienced a stroke died from this complication. The most frequently reported non-PFA specific minor events were haematoma, which occurred in 2.45% of the patients.

“This study showed us a reassuring safety profile of PFA with the pentaspline catheter, in particular with respect to oesophageal fistulae, the most devastating complication in PVI,” concluded discussant Dr Tom De Potter (Cardiovascular Research Center Aalst, Belgium).

1. Verma A, et al. Circ Arrhythm Electrophysiol. 2022;15(1):e010168.
2. Di Monaco A, et al. J Cardiovasc Dev Dis. 2022;9(4):94.
3. Reddy V, et al. MANIFEST-PF: multi-national survey on methods, efficacy and safety on the post-approval clinical use of pulsed field ablation. Late-breaking science 2, EHRA 2022, 3–5 April, Copenhagen, Denmark.

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Posted on 1 June 202213 June 2022