Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

NCT03239262 | Completed

• 1 other identifier: FNO-Cardiosurgery-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.

Conditions

Mitral Valve Disease; Coronary Artery Disease; Tricuspid Valve Disease; Aortic Valve Disease; Atrial Fibrillation

Keywords

Atrial Fibrillation; Left Atrial Cryoablation; Ganglionated Plexi; Open-Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Sinus Rhythm

  The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.

  30 months

Secondary Outcomes (1)

• Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery

  30 months

Study Arms (2)

Group GP

EXPERIMENTAL

Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).

Procedure: Concomitant Mapping and Radiofrequency Ablation

Group LA

EXPERIMENTAL

Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).

Procedure: No intervention

Interventions

Concomitant Mapping and Radiofrequency Ablation PROCEDURE

Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall. GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure\>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.

Group GP

No intervention PROCEDURE

No intervention was performed in patients without ganglionated plexi.

Group LA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
• Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
• Signing of the informed consent

You may not qualify if:

• Age below 40 and over 80 years of age
• Left ventricular ejection fraction below 25%
• Left atrium diameter over 60mm
• Permanent atrial fibrillation
• Polymorbidity (Euroscore II over 10)
• Emergency surgery
• Renal insufficiency (creatinine over 200 umol/l)

Sponsors & Collaborators

• University Hospital Ostrava: lead

Related Publications (6)

• Hou Y, Scherlag BJ, Lin J, Zhang Y, Lu Z, Truong K, Patterson E, Lazzara R, Jackman WM, Po SS. Ganglionated plexi modulate extrinsic cardiac autonomic nerve input: effects on sinus rate, atrioventricular conduction, refractoriness, and inducibility of atrial fibrillation. J Am Coll Cardiol. 2007 Jul 3;50(1):61-8. doi: 10.1016/j.jacc.2007.02.066. Epub 2007 Jun 18.

  PMID: 17601547 BACKGROUND

• Katritsis DG, Giazitzoglou E, Zografos T, Pokushalov E, Po SS, Camm AJ. Rapid pulmonary vein isolation combined with autonomic ganglia modification: a randomized study. Heart Rhythm. 2011 May;8(5):672-8. doi: 10.1016/j.hrthm.2010.12.047. Epub 2010 Dec 31.

  PMID: 21199686 BACKGROUND

• Edgerton JR, Brinkman WT, Weaver T, Prince SL, Culica D, Herbert MA, Mack MJ. Pulmonary vein isolation and autonomic denervation for the management of paroxysmal atrial fibrillation by a minimally invasive surgical approach. J Thorac Cardiovasc Surg. 2010 Oct;140(4):823-8. doi: 10.1016/j.jtcvs.2009.11.065. Epub 2010 Mar 17.

  PMID: 20299028 BACKGROUND

• Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.

  PMID: 20227287 BACKGROUND

• Pokushalov E, Romanov A, Shugayev P, Artyomenko S, Shirokova N, Turov A, Katritsis DG. Selective ganglionated plexi ablation for paroxysmal atrial fibrillation. Heart Rhythm. 2009 Sep;6(9):1257-64. doi: 10.1016/j.hrthm.2009.05.018. Epub 2009 May 20.

  PMID: 19656736 BACKGROUND

• Gelsomino S, Lozekoot P, La Meir M, Lorusso R, Luca F, Rostagno C, Renzulli A, Parise O, Matteucci F, Gensini GF, Crjins HJ, Maessen JG. Is ganglionated plexi ablation during Maze IV procedure beneficial for postoperative long-term stable sinus rhythm? Int J Cardiol. 2015 Aug 1;192:40-8. doi: 10.1016/j.ijcard.2015.04.259. Epub 2015 May 1.

  PMID: 25985014 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease; Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jiri Barta, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

• Radim Brat, MD,PhD,MBA

  University Hospital Ostrava

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of patients undergoing standard treatment have been compared retrospectively.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 4, 2017
• Study Start: July 1, 2012
• Primary Completion: January 31, 2016
• Study Completion: February 28, 2016
• Last Updated: August 4, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share