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Pregled bibliografske jedinice broj: 1250542

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

Ekanem, Emmanuel; Reddy, Vivek Y; Schmidt, Boris; Reichlin, Tobias; Neven, Kars; Metzner, Andreas; Hansen, Jim; Blaauw, Yuri; Maury, Philippe; Arentz, Thomas et al.
Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF) // EP Europace, 24 (2022), 8; 1256-1266 doi:10.1093/europace/euac050 (međunarodna recenzija, članak, znanstveni)

CROSBI ID: 1250542 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

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

Autori
Ekanem, Emmanuel ; Reddy, Vivek Y ; Schmidt, Boris ; Reichlin, Tobias ; Neven, Kars ; Metzner, Andreas ; Hansen, Jim ; Blaauw, Yuri ; Maury, Philippe ; Arentz, Thomas ; Sommer, Philipp ; Anic, Ante ; Anselme, Frederic ; Boveda, Serge ; Deneke, Tom ; Willems, Stephan ; van der Voort, Pepijn ; Tilz, Roland ; Funasako, Moritoshi ; Scherr, Daniel ; Wakili, Reza ; Steven, Daniel ; Kautzner, Josef ; Vijgen, Johan ; Jais, Pierre ; Petru, Jan ; Chun, Julian ; Roten, Laurent ; Füting, Anna ; Rillig, Andreas ; Mulder, Bart A ; Johannessen, Arne ; Rollin, Anne ; Lehrmann, Heiko ; Sohns, Christian ; Jurisic, Zrinka ; Savoure, Arnaud ; Combes, Stephanes ; Nentwich, Karin ; Gunawardene, Melanie ; Ouss, Alexandre ; Kirstein, Bettina ; Manninger, Martin ; Bohnen, Jan Eric ; Sultan, Arian ; Peichl, Petr ; Koopman, Pieter ; Derval, Nicolas ; Turagam, Mohit K ; Neuzil, Petr ; MANIFEST-PF Cooperative

Izvornik
EP Europace (1099-5129) 24 (2022), 8; 1256-1266

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Atrial fibrillation ; Catheter ablation ; Pulsed field ablation ; Survey.

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti



POVEZANOST RADA

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KBC Split

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Avatar Url Zrinka Jurišić (autor)

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Citiraj ovu publikaciju:

Ekanem, Emmanuel; Reddy, Vivek Y; Schmidt, Boris; Reichlin, Tobias; Neven, Kars; Metzner, Andreas; Hansen, Jim; Blaauw, Yuri; Maury, Philippe; Arentz, Thomas et al.
Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF) // EP Europace, 24 (2022), 8; 1256-1266 doi:10.1093/europace/euac050 (međunarodna recenzija, članak, znanstveni)
Ekanem, E., Reddy, V., Schmidt, B., Reichlin, T., Neven, K., Metzner, A., Hansen, J., Blaauw, Y., Maury, P. & Arentz, T. (2022) Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). EP Europace, 24 (8), 1256-1266 doi:10.1093/europace/euac050.
@article{article, author = {Ekanem, Emmanuel and Reddy, Vivek Y and Schmidt, Boris and Reichlin, Tobias and Neven, Kars and Metzner, Andreas and Hansen, Jim and Blaauw, Yuri and Maury, Philippe and Arentz, Thomas and Sommer, Philipp and Anic, Ante and Anselme, Frederic and Boveda, Serge and Deneke, Tom and Willems, Stephan and van der Voort, Pepijn and Tilz, Roland and Funasako, Moritoshi and Scherr, Daniel and Wakili, Reza and Steven, Daniel and Kautzner, Josef and Vijgen, Johan and Jais, Pierre and Petru, Jan and Chun, Julian and Roten, Laurent and F\"{u}ting, Anna and Rillig, Andreas and Mulder, Bart A and Johannessen, Arne and Rollin, Anne and Lehrmann, Heiko and Sohns, Christian and Jurisic, Zrinka and Savoure, Arnaud and Combes, Stephanes and Nentwich, Karin and Gunawardene, Melanie and Ouss, Alexandre and Kirstein, Bettina and Manninger, Martin and Bohnen, Jan Eric and Sultan, Arian and Peichl, Petr and Koopman, Pieter and Derval, Nicolas and Turagam, Mohit K and Neuzil, Petr}, year = {2022}, pages = {1256-1266}, DOI = {10.1093/europace/euac050}, keywords = {Atrial fibrillation, Catheter ablation, Pulsed field ablation, Survey.}, journal = {EP Europace}, doi = {10.1093/europace/euac050}, volume = {24}, number = {8}, issn = {1099-5129}, title = {Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)}, keyword = {Atrial fibrillation, Catheter ablation, Pulsed field ablation, Survey.} }
@article{article, author = {Ekanem, Emmanuel and Reddy, Vivek Y and Schmidt, Boris and Reichlin, Tobias and Neven, Kars and Metzner, Andreas and Hansen, Jim and Blaauw, Yuri and Maury, Philippe and Arentz, Thomas and Sommer, Philipp and Anic, Ante and Anselme, Frederic and Boveda, Serge and Deneke, Tom and Willems, Stephan and van der Voort, Pepijn and Tilz, Roland and Funasako, Moritoshi and Scherr, Daniel and Wakili, Reza and Steven, Daniel and Kautzner, Josef and Vijgen, Johan and Jais, Pierre and Petru, Jan and Chun, Julian and Roten, Laurent and F\"{u}ting, Anna and Rillig, Andreas and Mulder, Bart A and Johannessen, Arne and Rollin, Anne and Lehrmann, Heiko and Sohns, Christian and Jurisic, Zrinka and Savoure, Arnaud and Combes, Stephanes and Nentwich, Karin and Gunawardene, Melanie and Ouss, Alexandre and Kirstein, Bettina and Manninger, Martin and Bohnen, Jan Eric and Sultan, Arian and Peichl, Petr and Koopman, Pieter and Derval, Nicolas and Turagam, Mohit K and Neuzil, Petr}, year = {2022}, pages = {1256-1266}, DOI = {10.1093/europace/euac050}, keywords = {Atrial fibrillation, Catheter ablation, Pulsed field ablation, Survey.}, journal = {EP Europace}, doi = {10.1093/europace/euac050}, volume = {24}, number = {8}, issn = {1099-5129}, title = {Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)}, keyword = {Atrial fibrillation, Catheter ablation, Pulsed field ablation, Survey.} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE

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