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

Coronary Artery Disease Clinical Trial

Official title:

Assessment of the Effect of Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation in Patients Undergoing Open Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239262
• Other study ID #: FNO-Cardiosurgery-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2017
• Last updated: July 31, 2017
• Start date: July 1, 2012
• Est. completion date: February 28, 2016

Study information

• Verified date: July 2017
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between July 2012 and December 2014. The patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of Marshall.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2016
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aortic Valve Disease
• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Disease
• Myocardial Ischemia
• Tricuspid Valve Disease

Intervention

Procedure:
• Concomitant Mapping and Radiofrequency Ablation
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.
• No intervention
No intervention was performed in patients without ganglionated plexi.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

References & Publications (6)

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. — View Citation

Gelsomino S, Lozekoot P, La Meir M, Lorusso R, Lucà 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. — View Citation

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. Epub 2007 Jun 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus Rhythm	The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.	30 months
Secondary	Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery	The secondary outcome was the detection of relationship between the recurrence of atrial fibrillation and the presence of a mitral valve surgery, the presence of a mitral and tricuspid valves surgery and the left atrium diameter >50 mm.	30 months