Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―

Christian H. Heeger; Huong Lan Phan; Roza Meyer-Saraei; Thomas Fink; Vanessa Sciacca; Spyridon Liosis; Ben Brüggemann; Niels Große; Bezhad Fahimi; Makoto Sano; Karl Heinz Kuck; Feifan Ouyang; Julia Vogler; Charlotte Eitel; Roland Richard Tilz

doi:10.1253/circj.CJ-19-0766

Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―

Christian H. Heeger^*, Huong Lan Phan, Roza Meyer-Saraei, Thomas Fink, Vanessa Sciacca, Spyridon Liosis, Ben Brüggemann, Niels Große, Bezhad Fahimi, Makoto Sano, Karl Heinz Kuck, Feifan Ouyang, Julia Vogler, Charlotte Eitel, Roland Richard Tilz

^*Corresponding author for this work

Clinic of Internal Medicine II - Cardiology

Fuwai Hospital

24 Citations (Scopus)

Abstract

Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. Methods and Results: A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience. Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.

Original language	English
Journal	Circulation Journal
Volume	83
Issue number	12
Pages (from-to)	2443-2451
Number of pages	9
ISSN	1346-9843
DOIs	https://doi.org/10.1253/circj.CJ-19-0766
Publication status	Published - 25.11.2019

Funding

C.-H.H. received travel grants and research grants from Medtronic, Boston Scientific, Claret Medical, SentreHeart, Biosense Webster and Cardiofocus, and Speaker’s Honoraria from Biosense Webster, Cardiofocus and Boston Scientific. R.R.T. received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, and SentreHeart; Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, and Sano Aventis; and research grants by Cardiofocus. C.E. received travel grants and educational grants from Medtronic. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, and Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received Speaker’s Honoraria from Medtronic. All other authors have no relevant disclosures.

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This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1253/circj.CJ-19-0766

Cite this

Heeger, C. H., Phan, H. L., Meyer-Saraei, R., Fink, T., Sciacca, V., Liosis, S., Brüggemann, B., Große, N., Fahimi, B., Sano, M., Kuck, K. H., Ouyang, F., Vogler, J., Eitel, C., & Tilz, R. R. (2019). Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―. Circulation Journal, 83(12), 2443-2451. https://doi.org/10.1253/circj.CJ-19-0766

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title = "Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―",

abstract = "Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. Methods and Results: A total of 45 consecutive patients (89\% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98\%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7\%, with a trend towards a lower complication rate with increasing experience. Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.",

author = "Heeger, \{Christian H.\} and Phan, \{Huong Lan\} and Roza Meyer-Saraei and Thomas Fink and Vanessa Sciacca and Spyridon Liosis and Ben Br{\"u}ggemann and Niels Gro{\ss}e and Bezhad Fahimi and Makoto Sano and Kuck, \{Karl Heinz\} and Feifan Ouyang and Julia Vogler and Charlotte Eitel and Tilz, \{Roland Richard\}",

note = "Funding Information: C.-H.H. received travel grants and research grants from Medtronic, Boston Scientific, Claret Medical, SentreHeart, Biosense Webster and Cardiofocus, and Speaker{\textquoteright}s Honoraria from Biosense Webster, Cardiofocus and Boston Scientific. R.R.T. received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, and SentreHeart; Speaker{\textquoteright}s Bureau Honoraria from Biosense Webster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, and Sano Aventis; and research grants by Cardiofocus. C.E. received travel grants and educational grants from Medtronic. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, and Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received Speaker{\textquoteright}s Honoraria from Medtronic. All other authors have no relevant disclosures. Publisher Copyright: {\textcopyright} 2019 Japanese Circulation Society. All rights reserved. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

year = "2019",

month = nov,

day = "25",

doi = "10.1253/circj.CJ-19-0766",

language = "English",

volume = "83",

pages = "2443--2451",

journal = "Circulation Journal",

issn = "1346-9843",

publisher = "Japanese Circulation Society",

number = "12",

}

Heeger, CH, Phan, HL, Meyer-Saraei, R, Fink, T, Sciacca, V, Liosis, S, Brüggemann, B, Große, N, Fahimi, B, Sano, M, Kuck, KH, Ouyang, F, Vogler, J, Eitel, C & Tilz, RR 2019, 'Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―', Circulation Journal, vol. 83, no. 12, pp. 2443-2451. https://doi.org/10.1253/circj.CJ-19-0766

Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―. / Heeger, Christian H.; Phan, Huong Lan; Meyer-Saraei, Roza et al.
In: Circulation Journal, Vol. 83, No. 12, 25.11.2019, p. 2443-2451.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―

AU - Heeger, Christian H.

AU - Phan, Huong Lan

AU - Meyer-Saraei, Roza

AU - Fink, Thomas

AU - Sciacca, Vanessa

AU - Liosis, Spyridon

AU - Brüggemann, Ben

AU - Große, Niels

AU - Fahimi, Bezhad

AU - Sano, Makoto

AU - Kuck, Karl Heinz

AU - Ouyang, Feifan

AU - Vogler, Julia

AU - Eitel, Charlotte

AU - Tilz, Roland Richard

N1 - Funding Information: C.-H.H. received travel grants and research grants from Medtronic, Boston Scientific, Claret Medical, SentreHeart, Biosense Webster and Cardiofocus, and Speaker’s Honoraria from Biosense Webster, Cardiofocus and Boston Scientific. R.R.T. received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, and SentreHeart; Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, and Sano Aventis; and research grants by Cardiofocus. C.E. received travel grants and educational grants from Medtronic. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, and Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received Speaker’s Honoraria from Medtronic. All other authors have no relevant disclosures. Publisher Copyright: © 2019 Japanese Circulation Society. All rights reserved. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2019/11/25

Y1 - 2019/11/25

N2 - Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. Methods and Results: A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience. Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.

AB - Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. Methods and Results: A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience. Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.

UR - https://www.scopus.com/pages/publications/85075783700

U2 - 10.1253/circj.CJ-19-0766

DO - 10.1253/circj.CJ-19-0766

M3 - Journal articles

C2 - 31708555

AN - SCOPUS:85075783700

SN - 1346-9843

VL - 83

SP - 2443

EP - 2451

JO - Circulation Journal

JF - Circulation Journal

IS - 12

ER -

Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy ― the MERLIN registry ―

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