Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

Abstract

Aims Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the ‘real world’ performance of the only approved PFA catheter, including acute effectiveness and safety—in particular, rare oesophageal effects and other unforeseen PFA-related complications. Methods and results This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7–291), full cohort included 1758 patients: mean age 61.6 years (range 19–92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9–100%). Procedure time was 65 min (38–215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). Conclusion In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of ‘generic’ catheter complications (tamponade, stroke) underscores the need for improvement.

Pulsed field ablation in patients with complex consecutive atrial tachycardia in conjunction with ultra‐high density mapping: Proof of concept

“…In our study, we were able to create and block all anterior, roof and mitral isthmus lines with PFA. In the recently published Manifest PF survey of 24 European centers, roof lines and mitral isthmus lines were frequently deployed in 12.5% and 4.2% and sometimes in 25% and 33.2% of the participating centers, respectively 22 . Anterior lines were not frequently performed in any center but sometimes in 25% 22 .…”

“…In the recently published Manifest PF survey of 24 European centers, roof lines and mitral isthmus lines were frequently deployed in 12.5% and 4.2% and sometimes in 25% and 33.2% of the participating centers, respectively. 22 Anterior lines were not frequently performed in any center but sometimes in 25%. 22 This survey supports our data for feasibility of this PFA-guided ablation strategy.…”

“…Also, in the Manifest-PF survey no esophageal lesion was found in a large patient cohort of 1758 patients undergoing PFA including LAPWI in a minor portion of patients. 22…”

“…Therefore, PFAguided mitral isthmus ablation was performed in this one patient. LAPW (n = 10) 16 [11][12][13][14][15][16][17][18][19][20] Mitral isthmus line (n = 1) 4 Anterior line (n = 11) 20 [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] Roof line (n = 13) 7 [6][7][8][9][10][11] Ridge (n = 1) 20 [20] LAA (n = 1) 4 Total All complications, n (%) 0 (0.0)…”

Percutaneous Treatment Approaches in Atrial Fibrillation: Current Landscape and Future Perspectives

“…Moreover, the rate of short- and mid-term adverse events was very low. In the latest report of the MANIFEST-PF registry, PVI with PFA was accomplished in 99.9% of patients, with a low rate of major complications [ 95 ]. However, antral PVI may not be adequately achieved through PFA, since an insufficient isolation of the left anterior antral PV segments and enlarged LA isolation areas on the posterior segments was detected by Bohnen et al [ 96 ].…”