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Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.

Publication ,  Journal Article
Dukkipati, SR; Cuoco, F; Kutinsky, I; Aryana, A; Bahnson, TD; Lakkireddy, D; Woollett, I; Issa, ZF; Natale, A; Reddy, VY ...
Published in: J Am Coll Cardiol
September 22, 2015

BACKGROUND: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. OBJECTIVES: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. METHODS: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. RESULTS: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. CONCLUSIONS: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

September 22, 2015

Volume

66

Issue

12

Start / End Page

1350 / 1360

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pulmonary Veins
  • Prospective Studies
  • Middle Aged
  • Male
  • Learning Curve
  • Humans
  • Female
  • Endoscopy
  • Catheter Ablation
 

Citation

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Dukkipati, S. R., Cuoco, F., Kutinsky, I., Aryana, A., Bahnson, T. D., Lakkireddy, D., … HeartLight Study Investigators, . (2015). Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol, 66(12), 1350–1360. https://doi.org/10.1016/j.jacc.2015.07.036
Dukkipati, Srinivas R., Frank Cuoco, Ilana Kutinsky, Arash Aryana, Tristram D. Bahnson, Dhanunjaya Lakkireddy, Ian Woollett, et al. “Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.J Am Coll Cardiol 66, no. 12 (September 22, 2015): 1350–60. https://doi.org/10.1016/j.jacc.2015.07.036.
Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, et al. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350–60.
Dukkipati, Srinivas R., et al. “Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.J Am Coll Cardiol, vol. 66, no. 12, Sept. 2015, pp. 1350–60. Pubmed, doi:10.1016/j.jacc.2015.07.036.
Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY, HeartLight Study Investigators. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350–1360.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

September 22, 2015

Volume

66

Issue

12

Start / End Page

1350 / 1360

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pulmonary Veins
  • Prospective Studies
  • Middle Aged
  • Male
  • Learning Curve
  • Humans
  • Female
  • Endoscopy
  • Catheter Ablation