BACKGROUND: High-intensity focused ultrasound (HIFU) can achieve pulmonary vein isolation (PVI), but there are safety concerns after severe complications. Therefore, we evaluated an esophageal temperature (ET)-guided safety algorithm to apply HIFU safely. METHODS AND RESULTS: After standard left atrial access, HIFU was repeatedly applied until PVI was complete. A safety algorithm was used: <or=3 complete ablations per pulmonary vein (PV), early abortion when no effect after 50%of programmed time or when ET was >or=40.0 degrees C, use of power modulation (PM) at ET 39.0 degrees C: to reduce ablation temperature in surrounding tissue, acoustic power is switched on/off at 1 Hz; in all first ablations, use of PM after 50% of programmed time. Touch-up radiofrequency ablation was used when PVI failed. Periprocedural ET monitoring and endoscopy 2 days after ablation were performed. Twenty-eight patients (18 males; mean age at enrollment, 63 years), with paroxysmal atrial fibrillation (AF; n=19) and persistent AF (n=9) were included. In 84 of 109 PV (9 of 25 patients), PVI was achieved using HIFU only. In 9 of 109 PV, HIFU was aborted because of high ET. Mean ET at the end of the ablations with and without use of PM were 38.1+/-2.0 degrees C and 37.4+/-1.0 degrees C (P=0.0002). During endoscopy in 2 of 26 patients, a small thermal lesion was found. Other complications included 2 persistent phrenic nerve palsies, 1 ischemic stroke, 1 pericardial effusion 48 days after ablation, 1 unexplained death 49 days after ablation, and 1 lethal atrial-to-esophageal fistula 31 days after ablation. CONCLUSIONS: The safety algorithm failed to prevent lethal complications. Currently HIFU does not meet the safety standards required for treatment of atrial fibrillation.
BACKGROUND: High-intensity focused ultrasound (HIFU) can achieve pulmonary vein isolation (PVI), but there are safety concerns after severe complications. Therefore, we evaluated an esophageal temperature (ET)-guided safety algorithm to apply HIFU safely. METHODS AND RESULTS: After standard left atrial access, HIFU was repeatedly applied until PVI was complete. A safety algorithm was used: <or=3 complete ablations per pulmonary vein (PV), early abortion when no effect after 50%of programmed time or when ET was >or=40.0 degrees C, use of power modulation (PM) at ET 39.0 degrees C: to reduce ablation temperature in surrounding tissue, acoustic power is switched on/off at 1 Hz; in all first ablations, use of PM after 50% of programmed time. Touch-up radiofrequency ablation was used when PVI failed. Periprocedural ET monitoring and endoscopy 2 days after ablation were performed. Twenty-eight patients (18 males; mean age at enrollment, 63 years), with paroxysmal atrial fibrillation (AF; n=19) and persistent AF (n=9) were included. In 84 of 109 PV (9 of 25 patients), PVI was achieved using HIFU only. In 9 of 109 PV, HIFU was aborted because of high ET. Mean ET at the end of the ablations with and without use of PM were 38.1+/-2.0 degrees C and 37.4+/-1.0 degrees C (P=0.0002). During endoscopy in 2 of 26 patients, a small thermal lesion was found. Other complications included 2 persistent phrenic nerve palsies, 1 ischemic stroke, 1 pericardial effusion 48 days after ablation, 1 unexplained death 49 days after ablation, and 1 lethal atrial-to-esophageal fistula 31 days after ablation. CONCLUSIONS: The safety algorithm failed to prevent lethal complications. Currently HIFU does not meet the safety standards required for treatment of atrial fibrillation.
Authors: Hugh Calkins; Gerhard Hindricks; Riccardo Cappato; Young-Hoon Kim; Eduardo B Saad; Luis Aguinaga; Joseph G Akar; Vinay Badhwar; Josep Brugada; John Camm; Peng-Sheng Chen; Shih-Ann Chen; Mina K Chung; Jens Cosedis Nielsen; Anne B Curtis; D Wyn Davies; John D Day; André d'Avila; N M S Natasja de Groot; Luigi Di Biase; Mattias Duytschaever; James R Edgerton; Kenneth A Ellenbogen; Patrick T Ellinor; Sabine Ernst; Guilherme Fenelon; Edward P Gerstenfeld; David E Haines; Michel Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose Jalife; Jonathan M Kalman; Josef Kautzner; Hans Kottkamp; Karl Heinz Kuck; Koichiro Kumagai; Richard Lee; Thorsten Lewalter; Bruce D Lindsay; Laurent Macle; Moussa Mansour; Francis E Marchlinski; Gregory F Michaud; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Ken Okumura; Douglas Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Heart Rhythm Date: 2017-05-12 Impact factor: 6.343
Authors: Douglas L Miller; Nadine B Smith; Michael R Bailey; Gregory J Czarnota; Kullervo Hynynen; Inder Raj S Makin Journal: J Ultrasound Med Date: 2012-04 Impact factor: 2.153
Authors: Hugh Calkins; Karl Heinz Kuck; Riccardo Cappato; Josep Brugada; A John Camm; Shih-Ann Chen; Harry J G Crijns; Ralph J Damiano; D Wyn Davies; John DiMarco; James Edgerton; Kenneth Ellenbogen; Michael D Ezekowitz; David E Haines; Michel Haissaguerre; Gerhard Hindricks; Yoshito Iesaka; Warren Jackman; José Jalife; Pierre Jais; Jonathan Kalman; David Keane; Young-Hoon Kim; Paulus Kirchhof; George Klein; Hans Kottkamp; Koichiro Kumagai; Bruce D Lindsay; Moussa Mansour; Francis E Marchlinski; Patrick M McCarthy; J Lluis Mont; Fred Morady; Koonlawee Nademanee; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Douglas L Packer; Carlo Pappone; Eric Prystowsky; Antonio Raviele; Vivek Reddy; Jeremy N Ruskin; Richard J Shemin; Hsuan-Ming Tsao; David Wilber Journal: Heart Rhythm Date: 2012-03-01 Impact factor: 6.343
Authors: Hugh Calkins; Karl Heinz Kuck; Riccardo Cappato; Josep Brugada; A John Camm; Shih-Ann Chen; Harry J G Crijns; Ralph J Damiano; D Wyn Davies; John DiMarco; James Edgerton; Kenneth Ellenbogen; Michael D Ezekowitz; David E Haines; Michel Haissaguerre; Gerhard Hindricks; Yoshito Iesaka; Warren Jackman; Jose Jalife; Pierre Jais; Jonathan Kalman; David Keane; Young-Hoon Kim; Paulus Kirchhof; George Klein; Hans Kottkamp; Koichiro Kumagai; Bruce D Lindsay; Moussa Mansour; Francis E Marchlinski; Patrick M McCarthy; J Lluis Mont; Fred Morady; Koonlawee Nademanee; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Douglas L Packer; Carlo Pappone; Eric Prystowsky; Antonio Raviele; Vivek Reddy; Jeremy N Ruskin; Richard J Shemin; Hsuan-Ming Tsao; David Wilber Journal: J Interv Card Electrophysiol Date: 2012-03 Impact factor: 1.900
Authors: Babak Nazer; Edward P Gerstenfeld; Akiko Hata; Lawrence A Crum; Thomas J Matula Journal: J Interv Card Electrophysiol Date: 2013-12-03 Impact factor: 1.900